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

Model Number	DSF2065
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular treatment using gore¿ dryseal flex introducer sheath (dsf) for thoracic aortic aneurysm.The patients abdominal aorta had been replaced to y-shaped graft before the procedure (details unknown).An attempt was made to insert 20fr 65cm sheath (dsf2065) from the left femoral artery, but the dsf2065 stuck at the anastomotic site of y-shaped graft.Attempts were made to use the pull-through wire technique and dilator insertion, but these were unsuccessful.It was decided to exchange the dsf2065 to 20fr 33cm (dsf2033).The dsf2065 was removed, then blood pressure decreased and vascular damage was suspected.The dsf2033 was advanced, and occlusion was performed using a balloon catheter.The vitals became stable.The left internal iliac artery was embolized and two stent grafts were deployed to treat the rupture.The procedure for thoracic aortic aneurysm will be performed in the future.The physician stated as follows; the event was expected.It was a difficult case to access, so it can't be helped.

• Brand Name: GORE DRYSEAL FLEX INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12407299
• Report Number: 3007284313-2021-01565
• Device Sequence Number: 19928954
• Product Code: DYB
• UDI-Device Identifier: 00733132628360
• UDI-Public: 00733132628360
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: DSF2065
• Device Catalogue Number: DSF2065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR