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

Catalog Number PLC121400J

Device Problems Collapse (1099); Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), additional considerations for patient selection include but are not limited to the patient¿s anatomical suitability for endovascular repair.

Event Description

On (b)(6) 2017, this patient underwent endovascular repair of an abdominal aortic aneurysm using a system of gore® excluder® aaa endoprostheses.It was reported, pre-operative imaging identified a narrowed aortic bifurcation (exact measurement unknown).According to the report, the procedure concluded without any reported adverse events and final angiography showed exclusion of the aneurysms with patency of all devices.On (b)(6) 2017, follow-up imaging identified device lumen narrowing/compression of the contralateral leg component implanted on the patient¿s right side.No evidence of thrombus within the device was identified and the limb was reported to be patent without evidence of occlusion.The cause of the device compression is reportedly unknown, however it was reported the compression is believed to be caused by the patient¿s narrow/tight aortic bifurcation.On (b)(6) 2017, an additional procedure was performed to treat the device compression, whereby a metal stent (manufacturer unknown) was implanted to reline the contralateral leg component.Final angiography showed resolution of the compression, and the patient was reported to have tolerated the procedure.Images showing the compression were requested but reportedly were not available.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6981207
• MDR Text Key: 90387404
• Report Number: 2953161-2017-00199
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2017

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: 06/20/2020
• Device Catalogue Number: PLC121400J
• Device Lot Number: 16428620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 85 YR