MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER

Catalog Number DSF1233

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problem Vascular Dissection (3160)

Event Date 11/09/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on november 9, 2023, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses, gore® excluder® conformable aaa endoprostheses and gore® dryseal flex introducer sheaths as accessories.The contralateral leg endoprosthesis was deployed in the patients right side/contralateral side.The leg could not be pushed up enough to the target site and unintentionally covered the bifurcation of the right internal iliac artery, resulting in reduced blood flow to the right internal iliac artery.Although pushing up the leg by using the edge of the 12 fr sheath improved blood flow, a dissection occurred by the sheath edge and blood flow into the false lumen of the right common iliac artery was observed.As a treatment, an additional bare stent was implanted in the right external iliac artery and blood flow to the false lumen disappeared.An angiography confirmed delayed blood flow into the right internal iliac artery.When an aortic extender was deployed in the proximal side, it moved proximally and covered halfway of the renal artery.The patient tolerated the procedure and was decided to be monitored.The physician reported the selection of 10 cm leg was fine, but device push-up during deployment was not successful.The physician considered that pushing up the leg by the edge of the 12 fr sheath was risky, but as the patient¿s left internal iliac artery was coil embolized, blood flow preservation to the right internal iliac artery was a priority.Reportedly the patient¿s vessels were in poor condition including calcification.

Manufacturer Narrative

H.6: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6: code b20: device remains implanted and therefore not available for direct analysis.H.6.: code d1102 and code d12: according to the gore® dryseal flex sheath instructions for use, adverse events with may occur and/or require intervention including, but not limited to: vascular trauma (i.E., dissection, rupture, perforation, tear, etc.) 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.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.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18262961
• MDR Text Key: 329665981
• Report Number: 3007284313-2023-02913
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132629961
• UDI-Public: 00733132629961
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSF1233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female