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

Catalog Number VBH131002A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of a subclavian artery aneurysm with gore® viabahn® endoprostheses.Access was obtained using a 12fr sheath over an amplatz wire.A 10 mm x 5 cm gore® viabahn® endoprosthesis was advanced and deployed.Then a 13 mm x 10 cm device was advanced.Deployment was initiated, but when the deployment line was pulled, the line came all the way out without completing device expansion.The constrained section of the endoprosthesis was within the 10 mm x 5 cm device.The delivery catheter was cut to try to expose any remaining line.The endoprosthesis was stuck to the catheter in a tangled manner.It was not possible to retract this device.Through some maneuvers the device was pushed and pulled, but the constrained portion of the endoprosthesis broke free and floated into the aneurysm sac.The remainder of the device was re-sheathed and removed.Another 13 mm x 5 cm device was advanced and deployed, followed by a 13 mm x 5 cm device.The patient tolerated the procedure.

Manufacturer Narrative

H.6.Results code 2: 213: the engineering evaluation stated the following: the following observations were made: the contoured end of the endoprosthesis, part of the deployment line, and the entire delivery catheter were returned.The deployment line appeared to be broken with three single fibers coming from the end measuring approximately 17cm, 16.5cm, and 1.5cm.Part of the constraining line was still attached to the distal shaft, upon which the endoprosthesis was mounted.The delivery catheter appeared to be cut and resulted in three pieces.The pieces measured 71cm from the hub end, 34cm from the middle, and 22cm including the distal tip.The middle piece was stretched approximately 1.5cm, starting 6cm from the end.The piece that included the distal tip had cuts throughout the dual lumen and transition.The last two strut rows on the contoured end of the endoprosthesis were fully intact, while the rest of the stent wire appeared to be detached from the graft.Engineering evaluation conclusion is inconclusive as it relates to the event description.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8829337
• MDR Text Key: 152981410
• Report Number: 2017233-2019-00566
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623297
• UDI-Public: 00733132623297
• 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: 08/08/2019

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: 10/26/2021
• Device Catalogue Number: VBH131002A
• Device Lot Number: 19965419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR