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

Catalog Number JHJR062502J

Device Problems Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

Patient Problem Perforation of Vessels (2135)

Event Date 04/09/2019

Event Type  Injury  

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 underwent endovascular repair of a right superficial femoral artery occlusion using a gore® viabahn® endoprosthesis.The viabahn® device was deployed at the intended location with no reported issues.Post dilation was completed using a 6x150 shiden hp balloon: kaneka medix inflated to 30 atm (noted as higher than usual).Upon post-dilation it was reported that the balloon ruptured, and contrast from within the balloon was noted to be leaking outside of the viabahn® device.An angiography was performed, revealing that the contrast leak had originated from the middle of the device.The physician suspected that the viabahn® device and the patient's vessel had ruptured due to the post-dilation.It was noted that the patient's vessel was highly calcified.The rupture was repaired using another gore® viabahn® endoprosthesis.There were no further reported issues.The patient tolerated the procedure.

Manufacturer Narrative

G.5.Combination product corrected to "yes".

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8602166
• MDR Text Key: 144804175
• Report Number: 2017233-2019-00343
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Catalogue Number: JHJR062502J
• Device Lot Number: 18856791
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 70 YR