MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Catalog Number PAC101502

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.Udi # (b)(4).

Event Description

The patient presented with an aneurysm in the popliteal artery which was intended to be treated with a gore® viabahn® endoprosthesis.It was stated that access to the target vessel was gained homolateral.It was reported to gore that when medical device deployment was initiated some resistance were experienced during device deployment.It was stated that the endoprosthesis could be deployed finally, but that the deployment line of the device became stuck in the patient¿s artery or on the deployed endoprosthesis itself.It was sated that it is impossible to say where exactly the deployment line became stuck.The devices delivery catheter could be removed from the patient¿s vessel, but the deployment line was still stuck in the artery.It was stated that a balloon was inserted into the implanted endoprosthesis, to keep the device in position, and that a removal of the deployment line, where high force was requested, was attempted.It was reported to gore that the physician was not sure if the entire deployment line have been removed with this attempt.Consequently, two additional gore® viabahn® endoprostheses were implanted to ensure that no remaining deployment line portions will be floating free in the patient¿s artery.It was stated that the patient was doing well following the procedure.

Manufacturer Narrative

Our engineers have evaluated the returned device.Their investigation showed following: the catheter and deployment line attached to the knob were returned.The catheter appears unremarkable.The deployment line is approximately 224cm.There are two broken fibers that are loose in the deployment line.One single fiber is approximately 2.5cm long at 17.5cm from the end.A second single fiber is approximately 44.5cm long at 9.5cm from the end.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7368976
• MDR Text Key: 103808210
• Report Number: 2017233-2018-00187
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2019
• Device Catalogue Number: PAC101502
• Device Lot Number: 17378403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1