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

Catalog Number VBH131002A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Investigation is in progress pending the receipt and evaluation of images.

Event Description

As reported, the patient presented with a very tight venous stenosis.Target treatment site would not respond to a 12mm balloon dilation.A 13mm x 10cm gore viabahn endoprosthesis was positioned at the treatment site.During deployment, the device deployed; however, as the deployment line was removed from the introducer sheath, part of the nitinol wire appeared to be removed as well.Reportedly, the deployment line appeared wrapped around the nitinol wire.The end of the wire was cut releasing the deployment line.A 13mm x 5cm gore viabahn endoprosthesis device was then advanced though the sheath pushing the nitinol wire was pushed back into the sheath.At the end of the procedure, both of the devices appeared patent.The patient was fine post procedure.

Manufacturer Narrative

(b)(4).Images provided did not allow for evaluation in relation to the event.

• 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: roger smith ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5088330
• MDR Text Key: 26492818
• Report Number: 2017233-2015-00622
• 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: Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2018
• Device Catalogue Number: VBH131002A
• Device Lot Number: 14133328
• 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: 08/03/2015
• 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: 57 YR