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

Catalog Number VBC130502

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, a patient was to be implanted with gore® viabahn® endoprosthesis (item#: vbc130502; lot#: 12801759) for treatment of a knife injury to the superficial femoral artery.The device reportedly did not fully deploy and was removed out of the patient without injury.The physician used another viabahn vbc131002 to complete the procedure.

Manufacturer Narrative

Results pending completion of manufacturing,imaging and engineering evaluation.

Manufacturer Narrative

A review of the manufacturing paperwork is being conducted.

Manufacturer Narrative

(b)(4) - the review of the manufacturing records verified that the devices/lots met all pre-release specifications.Two specimens were returned for evaluation.The investigation stated that both devices, vbc131002 and vbc130502, were received fully deployed, with the endoprosthesis fully expanded.The catheter of both devices was unremarkable.Based on the devices examination performed, no manufacturing anomalies were identified.Conclusion - the gore® viabahn® endoprosthesis instructions for use (ifu) state complications and adverse events that can occur when using any endovascular device.These complications include, but are not limited to: deployment failure and migration.

Manufacturer Narrative

(b)(4).These complications include, but are not limited to: deployment failure and migration.

Manufacturer Narrative

• 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: helen huang ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4303593
• MDR Text Key: 5190065
• Report Number: 2017233-2014-00641
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup,Followup,Followup
• Report Date: 01/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2017
• Device Catalogue Number: VBC130502
• Device Lot Number: 12801759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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: 40 YR