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

Catalog Number PAHR060502E

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient presented with a thrombosed bypass within the superficial femoral artery / popliteal artery which was intended to be treated with a gore® viabahn® endoprosthesis.It was reported to gore that the endoprosthesis was successfully deployed at the distal end of the bypass without any abnormalities recognized.It was sated that when the delivery catheter was removed through the introducer sheath, a visual inspection indicated that the catheter shaft was broken and that the distal part of the device remained in the patient.An attempt was made to move the separated catheter shaft with the support of a balloon to the proximal end of the bypass.As further retraction of the catheter was not possible, an incision was made through the bypass to withdraw the catheter from the patient.It was reported that during this attempt the catheter was also cut into two pieces.After successfully device retrieval the bypass was sutured again and the procedure was completed.

Manufacturer Narrative

(b)(4).Device evaluation: our engineers have evaluated the returned device where the following observations were made: the deployment line and knob as well as the delivery catheter were returned.The endoprosthesis was not returned.The deployment line was fully intact and measured 151 cm long.The delivery catheter was returned in three pieces: dual lumen catheter bonded to the hub, transition bonded to some of the distal shaft (upon which the endoprosthesis was mounted), and the remainder of the distal shaft with the bonded distal tip.The dual lumen did not appear to have been melted to the transition.Part of the distal shaft, which sits inside the dual lumen catheter, also did not appear to have been melted, however, the distal shaft was melted to the transition.This part of the distal shaft was 0.5 cm.The opening where the deployment line enters the transition appeared to be melted.The other side of the distal shaft appeared to be cut and extended 0.3 cm past the transition.The remainder of the distal shaft with the bonded distal tip was 4.3 cm.The remainder of the device appeared unremarkable.Based on the device examination performed, manufacturing anomalies were identified that potentially could have contributed to the event.Further investigation and evaluation contained in failure investigation report.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7543648
• MDR Text Key: 109760088
• Report Number: 2017233-2018-00302
• 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: 06/10/2018

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: 07/16/2020
• Device Catalogue Number: PAHR060502E
• Device Lot Number: 17274524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention