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

Model Number DSF2033

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

The medical device was discarded at facility.Return not possible.(b)(4).

Event Description

On (b)(6) 2022, this patient underwent an endovascular treatment for a descending aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control system (ctag ac) and a gore® dryseal flex introducer sheath (dsf).As reported, the dsf was inserted from the right side but it was difficult to advance over the external iliac artery (eia).Reportedly, the diameter of the narrowest part of the eia was 6.0 to 6.1 mm.After the pta balloon inflation in the eia, the dsf was able to advance.The ctag ac was deployed just proximal to the superior mesenteric artery (sma), but the distal end was placed 2-3 mm more proximally than intended position.Therefore, an additional ctag ac was deployed just proximal to the sma.After implantation, an angiography for the access site showed dissection in the right eia.To treat it, an bare-metal stent (smart, 8mm x 60 mm) was placed at the dissected site.The final angiography showed no problem.The patient tolerated the procedure.

• 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: 14885738
• MDR Text Key: 295123545
• Report Number: 3007284313-2022-02012
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630066
• UDI-Public: 00733132630066
• 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
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF2033
• Device Catalogue Number: DSF2033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2021
• 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: 76 YR
• Patient Sex: Male