MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number PLC271200

Device Problem Compatibility Problem (2960)

Patient Problem Aneurysm (1708)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

Patient medications include but are not limited to: lisinopril,norvasc, lidotral cream.According to the instructions for use (ifu) for the gore® excluder® aaa endoprostheses; adverse events that may occur include, but are not limited to include: endoleak.A review of the manufacturing records for the device(s) verified the lot(s) met all pre-release specifications.

Event Description

On (b)(6) 2016, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system.It was reported that the physician was unable to cannulate the contralateral gate and after multiple attempts, cannulation was abandoned.An additional trunk ipsilateral leg endoprosthesis was used to perform an unplanned aorto-uni-iliac (aui), with a femoral bypass.The procedure was successfully concluded with implant of a contralateral leg component on the right side.On (b)(6) 2019, magnetic resonance angiography (mra) showed a distal type i endoleak on the right side caused by a lack of apposition and seal.There was aneurysm growth reported but the amount is unknown.On (b)(6) 2019, the patient underwent re-intervention.The right side was extended with an additional contralateral leg component down to the right external iliac artery, with coverage of the right internal iliac artery; and the aui was wired.The patient tolerated the procedure and the endoleak was resolved.

Manufacturer Narrative

Date of event: additional/corrected information.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8618189
• MDR Text Key: 145410777
• Report Number: 2953161-2019-00039
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618545
• UDI-Public: 00733132618545
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

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: 03/18/2019
• Device Catalogue Number: PLC271200
• Device Lot Number: 14889748
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 77