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

Catalog Number VBC070502

Device Problems Material Fragmentation (1261); Activation Failure (3270)

Patient Problems Occlusion (1984); Device Embedded In Tissue or Plaque (3165)

Event Date 09/04/2018

Event Type  Injury  

Event Description

It was reported to gore during a procedure for treatment of the abdominal aortic aneurysm a 6mm x 5cm gore® viabahn® endoprothesis was to be implanted as a branch graft in the left renal artery by a fenestration technique.After the viabahn® device was advanced through a cook long sheath to the target lesion inside the left renal artery, the deployment was initiated.No resistance was felt during pulling the deployment line.But the expansion of device reportedly started from the middle then went to the distal part, there still approximal 2cm proximal of stent was not expanded even after the deployment line was pulled out completely.The physician had to pull the catheter with extra force out of the patient, after the catheter was removed out, the distal shaft was observed being broken without a distal tip, which was separated and left inside the patient.The left renal artery was reportedly occluded.The procedure was ended without further treatment.According to the physician, the patient experienced a cancer of colon with invasion of the left kidney.The patient tolerated the procedure.The physician concerned a quality issue of the viabahn® device and requested an investigation.

Manufacturer Narrative

Conclusion code 1 corrected.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7888381
• MDR Text Key: 120693690
• Report Number: 2017233-2018-00564
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132614516
• UDI-Public: 00733132614516
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2020
• Device Catalogue Number: VBC070502
• Device Lot Number: 17776282
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 65 YR
• Patient Weight: 58