MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0); INTRODUCER, CATHETER

Catalog Number DSF1633

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Vascular Dissection (3160)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

According to the gore® dryseal flex introducer sheath instructions for use, 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.If vessel size is smaller than the nominal body od (table 1), major bleeding, vessel damage, or serious injury to the patient, including death, may result.

Event Description

On (b)(6) 2019, the patient underwent endovascular repair of an abdominal aortic aneurysm rupture with gore® excluder® aaa endoprostheses using a gore® dryseal flex introducer sheath (two 16fr and 12fr sheaths).A 16fr sheath was inserted from the left femoral artery, but it was difficult to advance.The physician changed an access site to the right side.The right external iliac artery was balloon expanded and the 16fr sheath was inserted from the right femoral artery, but it was also difficult to advance.Therefore the physician changed to a 12fr sheath, which was inserted successfully.The left external iliac artery was balloon expanded and a 16fr sheath was successfully inserted from the left femoral artery.When the sheath was removed, the imaging identified that the right common iliac artery and the left external iliac artery were dissected (please reference mfr report # 3007284313-2019-00203).An gore® excluder® aaa endoprostheses iliac extender component was implanted in the right common iliac artery to repair the right common iliac artery dissection.A stent (unknown manufacturer) was implanted in the left external iliac artery to repair the left external iliac dissection.The patient tolerated the procedure.In this procedure, two 16fr sheath were used, but it was unknown which sheath was involved with which dissection.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: douglas rhodes ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8784863
• MDR Text Key: 150847592
• Report Number: 3007284313-2019-00204
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630028
• UDI-Public: 00733132630028
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Catalogue Number: DSF1633
• Device Lot Number: 20419478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2019
• 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; Required Intervention
• Patient Age: 84 YR