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

Model Number	DSF2265
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment of an arch aortic saccular aneurysm using gore® tag® conformable thoracic stent graft with active control system and a 22fr gore® dryseal flex introducer sheath with 1 debranch bypass.The 22fr gore® dryseal flex introducer sheath was inserted from the right side.After all devices were implanted, upon closure of the access site, it was observed that blood flow of the right distal artery was poor.Angiography revealed a right iliac artery dissection.Two stents (smart) were implanted to treat the dissection.The dissection was resolved, and the blood flow improved.The physician stated that an angiography for the access site before closure was not clear and the evaluation of the access site might have not been sufficient.The physician suggested that the dissection might have occurred when the sheath was advanced.
Additional Manufacturer Narrative
(b)(4) according to the 22fr gore® dryseal flex introducer sheath sizing guide, the nominal outer diameter of the 22fr sheath is 8.2 mm.Reportedly, the right iliac artery at the site of the dissection was 7.0-8.1 mm in diameter.

• 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
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12828879
• Report Number: 3007284313-2021-01663
• Device Sequence Number: 1521130
• 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
• Report Date (Section B): 11/17/2021

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: 04/23/2024
• Device Model Number: DSF2265
• Device Catalogue Number: DSF2265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/17/2021
• Date Device Manufactured: 05/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male