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

Catalog Number PXC141400

Device Problems Break (1069); Premature Activation (1484); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient was implanted with gore excluder aaa endoprosthesis to treat an abdominal aortic aneurysm.It was reported the proximal aortic neck angled anteriorly ~60 degrees and the contralateral leg component delivery catheter was getting caught on the contralateral gate and could not be advanced.The device was reportedly pulled back into the introducer sheath when the trailing olive caught on the distal tip of the sheath adn the device unintentionally deployed.It was reported the leading olive and a portion of the polyimide shaft broke off and remained inside the patient on the guidewire.A snare was sued to remove the detached olive and polyimide, and an additional device was used to bridge the trunk and pxc141400.The patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Type of Device: MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): W. L. GORE & ASSOCIATES, INC.; 1327 orleans dr.; sunnyvale CA 94089
• Manufacturer Contact: shara blake ; 32470 n. north valley parkway; phoenix, AZ 85085 ; 9285263030
• MDR Report Key: 3752905
• MDR Text Key: 21733149
• Report Number: 2953161-2014-00011
• 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
• Report Date: 01/07/2014

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: 07/31/2016
• Device Catalogue Number: PXC141400
• Device Lot Number: 11751548
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2014
• Initial Date FDA Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2013
• 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: 67 YR
• Patient Weight: 125