MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBJ070502

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 04/05/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, an abdominal aortic aneurysm procedure was performed using a chimney technique.During this procedure, two gore® viabahn® endoprostheses were implanted in the left renal artery.By the end of the procedure, it was noticed the two gore® viabahn® endoprostheses had 'failed'.On (b)(6) 2014, patient suffered acute kidney injury that was contrast induced.The surgeon stated the acute renal injury came about as a result of the contrast plus the failed renal stent in one artery.

Manufacturer Narrative

Gore® viabahn® endoprosthesis, lot#12183914, mfr report #2017233-2014-00315 review of device manufacturing record history confirmed device met pre-release specifications.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3875559
• MDR Text Key: 4459997
• Report Number: 2017233-2014-00313
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• 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: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: VBJ070502
• Device Lot Number: 12360720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2014
• 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): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 58