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

Catalog Number VBCR071001A

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore: patient presented for treatment in left upper av cimino fistula outflow.A previously implanted graft (unknown manufacturer) existed at the target lesion.The intended treatment site was pre-ballooned.An 8fr sheath was used to advance the gore® viabahn® endoprosthesis.Due to the tight lesion with and an existing graft, the gore® viabahn® endoprosthesis encountered resistance and the distal tip broke off from the catheter.The catheter was withdrawn and the physician was able to retrieve the distal tip by inserting a longer sheath and isolating the tip.The patient did not experience any adverse consequences.

Manufacturer Narrative

The engineering evaluation was completed and observations were: a viabahn device with a loaded endoprosthesis was returned.The distal tip was separate from the rest of the delivery catheter.The distal shaft, upon which the endoprosthesis is mounted, was exposed 0.2 cm on the transition end.The distal tip end of the endoprosthesis measured 1 cm.This portion of the distal shaft¿s pebax does not appear to be interrupted.The distal tip remained on a guidewire and a small white piece of material consistent with plastic was sticking out of the transition end of the distal tip.After the distal tip was taken off of the guidewire, the white plastic piece could be removed from the distal tip.The radiopaque marker band remained attached to the white piece when it was removed from the distal tip.The white plastic piece measured 1.3 cm in length and 1.1 cm from the end of the marker band to the end of the piece.The white plastic piece transitions to a black color about half way through the length.The plastic piece is curved, fitting a similar shape to the inside of the distal tip.The piece is about 150° of the circumference of the distal tip when looking at the cross sectional area.The distal tip appears to have been melted since there is a ¿bump¿ approximately 0.5 cm the tip end of the distal tip.The inner diameter dimensions of the tip appear to be within the acceptable range.The white plastic piece is not a component used by the distal tip supplier and they do not know its origin.There is nothing in the viabahn manufacturing process that resembles this material or color.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: 7528045
• MDR Text Key: 109109588
• Report Number: 2017233-2018-00291
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Report Date: 06/08/2018

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: 03/08/2020
• Device Catalogue Number: VBCR071001A
• Device Lot Number: 16302457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8FR SHEATH
• Patient Age: 82 YR