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

Catalog Number VBHR080502A

Device Problem Material Separation (1562)

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

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that the lot met all pre-release specifications.

Event Description

On (b)(6) 2019, the patient was implanted with gore® viabahn® endoprostheses.It was reported the physician had dual access with two 12fr dryseal sheaths on the patients left side.It was reported the gore® viabahn® endoprostheses were implanted in the patient¿s left common iliac artery using a kissing technique.One (11x5) viabahn device was implanted retrograde from the groin.This device extended into the external iliac.A second (8x10) viabahn device was implanted antegrade from the axillary.This device reportedly extended into the internal iliac.The physician then placed a (9x15) viabahn device through the (8x10) viabahn device extending further into the internal artery.It was reported during extension of the (8x10) viabahn device into the common iliac artery a (8x5) viabahn device was advanced from the axillary sheath without issue into the (8x10) viabahn device in the common iliac.The physician deployed the stent fully.It was reported the deployment line broke at the hub of the catheter.The catheter was then removed without incident.There was reportedly no adverse events to the patient.

Manufacturer Narrative

Engineering evaluation states, based on the evaluation of the device, the following observations were made: no anomalies or non-routine maintenance were identified that could be attributed to the failure seen in this event.Therefore, based off of the evaluation performed, no manufacturing cause could be identified.Corrected conclusion code.

Manufacturer Narrative

Corrected g5 - combination product (yes).

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9218950
• MDR Text Key: 163309412
• Report Number: 2017233-2019-01071
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623303
• UDI-Public: 00733132623303
• 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
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2019
• Device Catalogue Number: VBHR080502A
• Device Lot Number: 16122360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR