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

Catalog Number VBJR060502A

Device Problems Failure to Unfold or Unwrap (1669); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem Aneurysm (1708)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing records indicated the device met pre-release specifications.The investigation is ongoing.

Event Description

The following was reported to gore: the patient presented for aortic aneurysm repair.The gore® viabahn® endoprosthesis (viabahn) was intended to be used as a snorkel device in the renal artery from a brachial approach.A 7fr destination sheath and two.014 spartecore wires were placed in the right and left renals.A 28 mm endurant graft, groin access, was placed in the aorta.The viabahn was advanced into place, in the renal, and the deployment line was pulled.The device partially opened then the deployment line frayed and broke.Attempts were made to access the remaining deployment line without success.The doctor decided to remove the partially deployed viabahn from the patient.When the viabahn was removed it was observed the 28 mm endurant graft covered the renals.However, according to the doctor, the renals were getting blood from somewhere.According to the doctor, the patient was doing well after the procedure was completed.

Manufacturer Narrative

Additional manufacturer narrative: examination of the returned device revealed the following: the deployment knob, deployment line, delivery catheter, as well as an introducer sheath were returned; the introducer sheath was not evaluated as it is not a gore product; the deployment line appeared to be broken and measured approximately 120cm; four single fibers measuring from 1.8cm to 2cm were protruding from the distal end of the introducer sheath; the delivery catheter appeared to be cut and resulted in 4 pieces; the pieces measured 1.6cm, 18cm, 12cm, and 25.5cm; the last piece was still inserted into the introducer sheath.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.All information has been placed on file for use in tracking and trending.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8749699
• MDR Text Key: 151425018
• Report Number: 2017233-2019-00487
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623952
• UDI-Public: 00733132623952
• 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: 07/02/2019

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: 10/13/2019
• Device Catalogue Number: VBJR060502A
• Device Lot Number: 15826070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 75