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

Model Number DSF2233

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Date 11/08/2020

Event Type  Injury  

Manufacturer Narrative

Patient weight: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.

Event Description

On (b)(6) 2020 the patient underwent emergency thoracic aortic endovascular repair to treat a descending thoracic aortic rupture.It was noted that heparin was not used in this case.A gore® dryseal flex introducer sheath was inserted from the patient's left side.A gore® tag® conformable thoracic stent graft with active control system was deployed and touch-up ballooning was performed to the proximal end of the device using a gore® tri-lobe balloon catheter.After the introducer sheath was removed, it was reported that angiography confirmed that the patient's left internal iliac artery was occluded.Reportedly there was no dissection of the artery.The physician reportedly considered that the non-heparin situation was a factor in the occlusion.It was reported that the patient's superior and inferior gluteal arteries had collateral blood flow.No additional treatment was performed for the occlusion.The procedure was completed, and the patient tolerated the procedure.

Manufacturer Narrative

H.6.Health effect - impact code added.H.6.Investigation conclusions code 4315 added h.6.Investigation findings code 3233 updated to code 213.H.6.Investigation conclusions code 11 updated to code 4311.

• 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
• MDR Report Key: 10962062
• MDR Text Key: 220193540
• Report Number: 3007284313-2020-01187
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: 00733132630073
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: DSF2233
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR