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

Model Number DSF1633

Device Problem Positioning Problem (3009)

Patient Problem Aneurysm (1708)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

According to the instructions for use (ifu) for the gore® dryseal flex introducer sheath, adverse events that may occur and / or require intervention include but are not limited to: vascular trauma (ie., dissection, rupture,perforation, tear, etc.) a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses using a gore® dryseal flex introducer sheath (dsf) as a conduit for the insertion of the endoprostheses to the intended deployment location.It was reported that the patient¿s left access vessels were significantly tortuous.Strong resistance was reported upon insertion of a 16fr dsf, and advancement required some force.Upon deployment of the contralateral leg endoprosthesis to extend the left limb, it was reported that the graft unintentionally moved distally some.An additional stent graft was deployed to reinforce the junction.A gore® molding & occlusion balloon (mob) was used for touch up angioplasty and during use it ruptured, no over inflation was reported.The mob was removed from the patient and another balloon catheter was used to complete touch up angioplasty.Post deployment of all stent grafts, angiography was performed and revealed a dissection in the tortuous part of the left external iliac artery (leia).An additional stent graft was deployed to treat the dissection.The patient tolerated the procedure.The physician stated that dsf had been inserted with force due to the tortuosity of the leia.

Manufacturer Narrative

B1/2: additional information g3/4 corrected information.

• Brand Name: GORE DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11057390
• MDR Text Key: 223194832
• Report Number: 3007284313-2020-01207
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00733132630028
• UDI-Public: 00733132630028
• 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: 06/18/2021

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: 06/11/2023
• Device Model Number: DSF1633
• Device Catalogue Number: DSF1633
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 06/18/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 84 YR