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

Model Number DSF1233

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rupture (2208)

Event Date 10/01/2021

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular treatment using gore® dryseal flex introducer sheath (dsf), gore® excluder® aaa endoprosthesis and non-gore stent graft for abdominal aortic aneurysm.It was reported that the patient's left common iliac artery was significant tortuous and calcified.During the procedure, when 12fr dsf was inserted, the delivery was difficult due to the tortuosity and calcification.The dsf was pushed with force, then the left common iliac artery ruptured.As blood pressure dropped, a stent graft was placed to treat the rupture.However, blood pressure didn¿t recover.It was decided to convert to aui (aorto-uni-iliac).A femoral-femoral artery cross bypass was performed.An additional non-gore stent graft was deployed inside the non-gore main body.The left common iliac artery was ligated.Type iv endoleak of the non-gore stent graft was observed, but no specific treatment was performed.The patient tolerated the procedure.The physician stated as follows; due to the high degree of tortuosity of the left cia (shape like a u-turn) and strong calcification, it did not rise even with dsf1233, and it was pushed in strongly, so the left cia was ruptured.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

H6: component code added.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12725620
• MDR Text Key: 282829072
• Report Number: 3007284313-2021-01637
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132629961
• UDI-Public: 00733132629961
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: DSF1233
• Device Catalogue Number: DSF1233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male