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

Catalog Number	DSF1833
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® dryseal flex introducer sheath instructions for use (ifu) states in the caution section: do not continue advancement or retraction of the catheter or other device into or out of the sheath if there is resistance.Determine the cause of resistance before proceeding.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that the physician met resistance while advancing a gore® dryseal flex sheath (dsf1833/[(b)(4)] 18069588), however he was eventually able to advance the flex sheath where it was needed.After the gore® excluder® aaa endoprostheses were implanted successfully, the physician ballooned the entire graft.The patient became unstable and experienced a cardiac tamponade.The physician opened the patient and found the patient was bleeding from the lumbar arteries, he believes that during the procedure calcium became dislodged and lacerated the iliolumbar artery which extended into the aneurysm sac.The physician chose to explant the gore® excluder® aaa endoprostheses and perform an open repair.The patient tolerated the procedure.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7862966
• Report Number: 3007284313-2018-00256
• Device Sequence Number: 16436846
• Product Code: DYB
• UDI-Device Identifier: 00733132600656
• UDI-Public: 00733132600656
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2023
• Device Catalogue Number: DSF1833
• Device Lot Number: 18169588
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 76 YR