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

Catalog Number PAH131002

Device Problem Failure to Disconnect (2541)

Patient Problems Occlusion (1984); Thromboembolism (2654)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cook 14fr flexor check-flo; boston scientific 0.035¿ thruway guidewire.Further investigation is being conducted and will be included in the final report.

Event Description

The patient was presented with a aneurysm in the right popliteal artery which was treated with the placement of a gore viabahn endoprosthesis.A 14fr flexor check-flo (cook)introducer sheath was used to advance the device over a 0.035" thruway (boston scientific) guidewire.During the deployment procedure the deployment line did not detach fully from the device.With the removal of the catheter, the already opened gore viabahn endoprosthesis was pulled back into the aneurysm.Thrombus was loosened by doing that and occluded the fibular artery and partly occluded the posterior tibial artery.A anterior tibial artery was not existing.Finally the physician was able to remove the catheter.The physician unsuccessfully tried to treat the occlusion with aspiration, thrombolysis, angioplasty and administration of prostavasin.The patient is currently being monitored.

Manufacturer Narrative

Refer to field for the results of the imaging evaluation.Our engineers have evaluated the returned device.Their investigation showed following: the complete viabahn delivery system was returned to histology without the endoprosthesis.79cm of deployment line was protruding from the catheter tubing transition port upon examination of the device.Four single-fiber loops in were present in the deployment line at approximately 14cm, 15cm, 26cm, and 30cm from the frayed end of the deployment line.The deployment line had 4cm of slack at the hub.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: joerg kersten ; 9285263030
• MDR Report Key: 5250294
• MDR Text Key: 32129582
• Report Number: 2017233-2015-00840
• 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: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: PAH131002
• Device Lot Number: 14298708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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 Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 90