W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER
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Model Number DSF2233 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Calcium Deposits/Calcification (1758); Vascular Dissection (3160)
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Event Date 07/05/2022 |
Event Type
Injury
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Event Description
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On (b)(6) 2022, a patient underwent emergent endovascular treatment of a thoracic aortic aneurysm rupture using a 22 fr gore® dryseal flex introducer sheath.During the treatment, after stent grafts were implanted, a dissection was reportedly observed in the left external iliac artery.A bare stent was implanted to treat the dissection.The patient tolerated the procedure.The physician stated that resistance was felt while inserting the sheath due to calcification.The left external iliac artery measured a reported 6.6 to 7.6 mm in diameter.
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Manufacturer Narrative
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(b)(4).It should be noted the gore® dryseal flex introducer sheath instructions for use (ifu) state ¿adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.¿ per ifu, if vessel size is smaller than the nominal body outer diameter, major bleeding, vessel damage, or serious injury to the patient, including death, may result.The nominal outer body diameter of a 22 fr gore® dryseal flex introducer sheath is 8.2mm.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Added g3/g4, h1/h2 and h6.It should be noted the gore®dryseal flex introducer sheath instructions for use (ifu) state ¿adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.¿ per ifu, if vessel size is smaller than the nominal body outer diameter, major bleeding, vessel damage, or serious injury to the patient, including death, may result.The nominal outer body diameter of a 22 fr gore® dryseal flex introducer sheath is 8.2mm.
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