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

Catalog Number VBJ051002

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

Patient presented with a total occlusion in the popliteal artery.It was reported that the patient had highly calcified vessels.The target site was pre-dilated and a 6fr ansel cook sheath was used to advance the gore viabahn endoprosthesis over an.018 guidewire.During advancement, the gore viabahn endoprosthesis went in and out of the subintimal space.The gore viabahn endoprosthesis was delivered to target site and deployment was initiated.However, the deployment line broke while the proximal end of the device was still constrained.The gore viabahn® endoprosthesis was crushed between the native vessel and a bare metal stent (unknown manufacturer).The patient did not experience any adverse consequences.

Manufacturer Narrative

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: 3805608
• MDR Text Key: 15107841
• Report Number: 2017233-2014-00241
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• 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: VBJ051002
• Device Lot Number: 11752340
• 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: 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
• Treatment: 6FR ANSEL COOK SHEATH, .018 GUIDEWIRE
• Patient Age: 95 YR