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

Model Number DSF2233

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problem Perforation of Vessels (2135)

Event Date 11/28/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient underwent emergency endovascular treatment of a thoracic aneurysm rupture using two gore® dryseal flex introducer sheaths as accessories during the procedure.After stent graft implantation was successfully completed from the left side, it was reported that vessel damage ranging from the left common iliac to the left external iliac artery was observed upon withdrawal of the 22fr sheath.Three stent grafts were implanted to treat the vessel damage on the left side.The patient tolerated the procedure.It was reported that both access vessels were narrow and stenosed (minimum diameters are about 5-6mm in both right/left access arteries).Calcium was also reportedly seen in both vessels.Percutaneous balloon angioplasty was needed to insert the sheath on both sides.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was discarded at the facility and, therefore, was not available for direct analysis by gore.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.¿ additionally, per ifu, if vessel size is smaller than the nominal body outer diameter (8.2mm for a 22fr sheath), major bleeding, vessel damage, or serious injury to the patient, including death, may result.

• 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13061333
• MDR Text Key: 286920099
• Report Number: 3007284313-2021-01718
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: 00733132630073
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2024
• Device Model Number: DSF2233
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2021
• Initial Date FDA Received: 12/22/2021
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female