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

Catalog Number PAH111002E

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Physical Resistance (2578)

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

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).Further investigation is being conducted and the information will be included in the final report.

Event Description

The patient presented with a thrombosed aneurysm in the popliteal artery which was intended to be treated with two gore® viabahn® endoprostheses.The proximal part of the popliteal artery was measured with 9mm in diameter, the distal part was measured with 11mm in diameter.Therefore the case was planned to have a pah091002e implanted proximally and a pah111002e distally.It was reported to gore that when the distal gore® viabahn® endoprosthesis was implanted, deployment of the endoprosthesis stopped suddenly after 80% of the endoprosthesis was deployed.It was stated that some force was requested to continue device deployment.After the endoprosthesis was successfully deployed the device catheter could be removed but the deployment line remained on the endoprosthesis and could not be removed.Therefore the decision was made to implant a bare metal stent proximal to the first implanted gore® viabahn® endoprosthesis to fixate the deployment line on the patient¿s artery wall.After the bare metal stent was implanted a third gore® viabahn® endoprosthesis was implanted between the proximal and distal one to ensure a good alignment and deployment line fixation.After the endoprosthesis was successfully deployed and device catheter was removed a visual inspection proofed that the remaining deployment line caught up on the device catheter and could be removed together.The patient presented with a good blood flow in the upper limb and is doing well following the procedure.

Manufacturer Narrative

Our engineers have evaluated the returned device.Their investigation showed following: the delivery catheter was returned without the endoprosthesis, deployment line, or deployment knob.The returned components were unremarkable.As such, no conclusions can be made regarding the observed deployment difficulties.Engineering evaluation conclusion is inconclusive as it relates to the event description.Based on the device examination performed, no manufacturing anomalies were identified.

• 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 86005
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6430721
• MDR Text Key: 71094852
• Report Number: 2017233-2017-00147
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2019
• Device Catalogue Number: PAH111002E
• Device Lot Number: 15228812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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: 70 YR
• Patient Weight: 80