MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number VBCR070202A

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: 8fr vascular sheath.A review of the manufacturing records for the device is currently in progress.(b)(4).

Event Description

The following information was reported to gore: in a voluntarily submitted medwatch, it states the following: on (b)(6) 2018, a patient was undergoing fistulogram treatment with thrombectomy and angioplasty with stent graft deployment of a left arm hemodialysis graft.After the arterial plug and residual thrombus were removed, there was still a residual stenosis across the venous anastomosis.A gore® viabahn® endoprosthesis was advanced over a.035" guidewire to treat this stenosis.Following deployment, upon removal of the delivery catheter, it was noticed that the distal end of the catheter was missing.Fluoroscopy revealed that the fractured tip was still on the guidewire.The tip was able to be retrieved successfully.

Manufacturer Narrative

Conclusion code 2: updated.

Manufacturer Narrative

H.6.Results code 2: 213: the engineering evaluation stated the following: the following observations were made: only the delivery catheter was returned.The endoprosthesis, deployment knob, and deployment line were not returned.The distal tip bonded to the distal shaft, upon which the endoprosthesis was mounted, was separated from the transition and dual lumen.The transition end of the distal shaft did not appear to have an interruption in the pebax material.The distal shaft measured approximately 3.9 cm.The expected distal shaft length for this size device is 4.35 to 5.15 cm.The transition appears bonded to the dual lumen catheter shaft.Based on the device examination performed, anomalies were identified that could potentially be attributed to manufacturing.

Manufacturer Narrative

D.10.Updated e.1.Updated h.3.Updated.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8152045
• MDR Text Key: 130610944
• Report Number: 2017233-2018-00755
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623426
• UDI-Public: 00733132623426
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Catalogue Number: VBCR070202A
• Device Lot Number: 18338720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 62