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

Model Number VBH131002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 11/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a ¿brazilian snorkel¿ procedure was performed.Left brachial artery access was obtained and a gore® viabahn® endoprosthesis with heparin bioactive surface (13mm x 10cm) was advanced through a gore® excluder® aaa endoprosthesis contralateral leg (18mm x 9.5cm).The distal part of the gore® viabahn® endoprosthesis with heparin bioactive surface was placed in the left internal iliac artery with the proximal part remaining in the contralateral leg.There was access through the left femoral artery and a gore® excluder® aaa endoprosthesis contralateral leg (14mm x 10mm) was advanced into the left external iliac artery and contralateral leg.The gore® viabahn® endoprosthesis with heparin bioactive surface and excluder contralateral leg were placed side-by-side (or ¿sandwiched¿) inside the previously placed contralateral limb and deployed at the same time.The gore® viabahn® endoprosthesis with heparin bioactive surface was deployed in the contralateral leg and internal iliac artery and the excluder contralateral leg was deployed in the previously deployed contralateral leg and the external iliac artery.Ballooning was done and the aneurysm was excluded and patency was achieved.The patient tolerated the procedure.It was reported to gore that on or about november 1, 2014, computed tomography scan reportedly identified a dissection in the left external iliac artery.The cause of the dissection is unknown.The images are not available.On november 13, 2014, the physician extended the existing stent graft system by implanting an additional contralateral leg component (plc161400/12300824).The dissection was resolved, and the patient tolerated the procedure.

Manufacturer Narrative

Medications: synthroid, metoprolol, synthrex; (b)(6) 2014 gore® excluder® aaa endoprosthesis contralateral leg (18mm x 9.5cm), gore® excluder® aaa endoprosthesis contralateral leg (14mm x 10mm).No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device remained implanted; consequently, a direct product analysis was not possible.Without additional information it is impossible to further investigate this event.

Manufacturer Narrative

Results: a review of the manufacturing records for the device verified that the lot met all 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: sandra whicker ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4326455
• MDR Text Key: 15347664
• Report Number: 2017233-2014-00663
• 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,Followup
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: VBH131002
• Device Lot Number: 12713546
• 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: 06/09/2014
• 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: 69 YR
• Patient Weight: 91