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

Catalog Number PAH111002

Device Problems Retraction Problem (1536); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/05/2015

Event Type  Injury  

Event Description

The patient presented with an aneurysm in the popliteal artery.Three gore® viabahn® endoprostheses were used for the procedure.It was reported to gore that when the first viabahn device was implanted distally to the diseased lesion, the second device was introduced.When device deployment was initiated the deployment stopped suddenly after ¾ of deployment.It was not possible to pull the deployment line any further.While trying to pull the line the device moved proximally and fully deployed.The catheter was removed completely without any abnormalities but it was not possible to pull back the deployment line entirely.The line was cut at the very end of the introducer sheath and a third viabahn device was introduced to close the gap between the first and second one.The remaining deployment line remains in the patient.The final results was very good and the patient is doing well.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The imaging evaluation stated that the images provided do not allow for evaluation in relation to the event.The engineering evaluation is currently in process.

Manufacturer Narrative

The engineering evaluation stated that the following observations were made: the complete delivery system was returned to histology without the endoprosthesis.Approximately 161 cm of deployment line was returned with the device.The deployment line distal end had fibers of uneven length.The remainder of the device was unremarkable.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 86001
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4642630
• MDR Text Key: 5614957
• Report Number: 2017233-2015-00196
• 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: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2017
• Device Catalogue Number: PAH111002
• Device Lot Number: 13437884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2015
• 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
• Treatment: TWO GORE® VIABAHN® ENDOPROSTHESES
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 90