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

Model Number	DSF2265
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore¿ dryseal flex introducer sheath instructions for use sizing guide, the nominal outside diameter of the 22fr sheath is 8.2 mm.As reported, the left access vessel measured approximately 7 mm.
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment of a thoracic aortic aneurysm using gore¿ tag¿ conformable thoracic stent graft with active control system and a 22fr gore¿ dryseal flex introducer sheath.The gore¿ dryseal flex introducer sheath was inserted from the left access.Measurements of the left access vessel was approximately 7mm.After the gore¿ tag¿ conformable thoracic stent graft with active control system was implanted, and after the access site was closed, the physician noticed there was no pulse in the left limb.An angiography imaging revealed that there was no blood flow in the left common femoral artery to the left superficial femoral artery.A dissection was observed at the access site and an endarterectomy was performed.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: investigation findings, conclusion code.

• 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: 11826131
• Report Number: 3007284313-2021-01430
• Device Sequence Number: 1060452
• Product Code: DYB
• UDI-Device Identifier: 00733132628384
• UDI-Public: 00733132628384
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: 10/02/2022
• Device Model Number: DSF2265
• Device Catalogue Number: DSF2265
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 08/13/2021
• 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: 88 YR