apollo endosurgery X-Tack Gebrauchsanweisung Seite 3

- Do not advance or retract the X-Tack device through
a retroflexed scope (a scope that is curved more
than 180 degrees). This can damage the device and/
or the endoscope. If there is excessive resistance
to moving the device through the scope, reduce
the curvature in the scope (tortuosity) before
proceeding. This should reduce resistance.
- Applying excessive force to the distal end of the
X-Tack™ device could compress or damage the
HeliX Tack when installed.
- Do not retract device into scope whilst a HeliX Tack
is installed.
- Reuse or reprocessing of the X-Tack™ System could
result in device malfunction, patient infection or the
transmission of disease.
Precautions
- The system may only be used if purchased from Apollo
Endosurgery, Inc. or one of its authorized agents.
Adverse Events
Possible complications that may result from using the
X-Tack™ System include, but may not be limited to:
- Pharyngitis / Sore throat
- Nausea and / or Vomiting
- Abdominal pain and / or Bloating
- Pericardial tamponade
- Delayed bleeding
- Hemorrhage
- Hematoma
- Conversion to laparoscopic or open procedure
- Stricture
- Inflammation
- Infection / Sepsis
- Pharyngeal, gastric, colonic and/or esophageal
perforation
- Esophageal, gastric, colonic and/or pharyngeal
laceration
- Intra-abdominal (hollow or solid) visceral injury
- Pancreatitis
- Aspiration
- Wound dehiscence
- Acute inflammatory tissue reaction
- Death
NOTE: Any serious incident that has occurred in
relation to the device should be reported to Apollo
Endosurgery (see contact information at the end of
this document) and any appropriate government
entity.
Compatibility
- The system is compatible with an endoscope
(gastroscope or colonoscope) with a 2.8 mm or
larger working channel. Gastric and Colonic X-Tack
devices have scope channel liners of different
lengths, which are appropriately sized to protect a
2.8mm or larger gastroscope or colonoscope. The
system has been verified compatible with Olympus,
Pentax and Fuji gastroscopes. Note that the gastric
X-Tack scope liner is approximately 2 inches shorter
than the Fuji gastroscope channel. Take care when
introducing X-Tack into Fuji gastroscopes.
- The gastric X-Tack devices (X-Tack-160-H) are
intended to be used with OverStitch Suture Cinch
(CNH-G01-000).
- The colonic X-Tack devices (X-Tack-235-H) are
intended to be used with Suture Cinch - Long (CNH-
C01-213-L).
Implant Materials
- HeliX Tacks are manufactured from stainless steel.
Each HeliX Tack has a mass of 28 mg.
- Cinch implants are manufactured
polyetheretherketone (PEEK). It contains 0.020g of
PEEK material.
- Suture Materials:
- The suture is manufactured from an isotactic
crystalline stereoisomer of polypropylene, a
synthetic linear polyolefin.
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- The suture pigment uses CU-Phthalocyanine
Blue Dye (below 0.5 WT %) to enhance visibility.
- The suture material meets the requirements
established by USP .
- The length of the remaining suture is typically
1 cm in length (0.43 mg).
- The X-Tack System is not made from natural rubber
latex.
Lifetime Statement
- The functional device lifetime is anticipated to be
approximately 30 days. This is sufficient time to
permit healing and closure of a typical defect. It is
not abnormal for the HeliX Tacks to release from the
tissue one at a time. This is dependent on the tension
in the suture (after cinching) and the robustness of the
attachment between each individual HeliX Tack and the
gastrointestinal tract. Once a single tack releases from
the tissue, tension on the remaining tacks will likely be
reduced. Progressive tacks may release in this same
manner or due to the passage of gastrointestinal
contents past the construct. Released tacks will be
maintained on the suture. If and when the final tack
releases from tissue, the entire construct will be
from
passed in the stool. If this final tack does not release,
the construct may remain in the gastrointestinal tract.