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

Catalog Number PXC141400

Device Problems Premature Activation (1484); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.Pre-operative images reportedly identified heavily calcified and tortuous anatomy distal to the landing zone.It was reported a contralateral leg component was advanced outside of the sheath, rotated, and torqued excessively in an attempt to advance the device into the contralateral gate.When this reportedly proved unsuccessful, a left brachial approach was attempted to snare the contralateral leg component and pull it through the gate.It was reported that the graft was snared, but when the device was pulled into the gate, the device prematurely deployed ~1cm distal to the contralateral gate.Angiography reportedly showed the leading olive and part of the polyimide wire had separated from the delivery catheter and now remained within the contralateral gate and the contralateral leg component.The detached olive and polyimide wire were snared and removed from the patient, and an additional device was implanted to bridge the trunk-ipsilateral and contralateral leg components.Final angiography showed exclusion of the aneurysm, and the patient tolerated the procedure.

Manufacturer Narrative

Patient medications include pepcid, spiriva, zoloft, metoprolol, lisinopril, flovent, docusate, lipitor, aspirin, plavix, albuterol, tylenol, milk of magnesia and hydrocodone.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

Evaluation summary: the device and delivery catheter were returned to gore for evaluation.The guidewire and the introducer sheath were not returned and therefore unavailable for evaluation.Based on the available information and evaluation of the returned product, no root cause could be determined.However, use outside of the instructions for use was noted and may have contributed to this event.The root cause of the event could not be determined with the provided information.

• 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 86004 ; 9285263030
• MDR Report Key: 3658555
• MDR Text Key: 4353263
• Report Number: 2953161-2014-00026
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: PXC141400
• Device Lot Number: 12109549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2013
• 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 Age: 74 YR
• Patient Weight: 85