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

Catalog Number VBJR051002A

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records verified that the lot met release requirements.Examination of the returned device revealed the following: the endoprosthesis, delivery catheter, deployment knob, and two sections of deployment line were returned.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Event Description

The following was reported to gore by the hospital: the doctor placed a gore® viabahn® endoprosthesis in a patient's popliteal artery.While it was being deployed the deployment line broke (it wasn't deployed all the way).The doctor was already in the or and was able to remove the device surgically.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8993137
• MDR Text Key: 157480855
• Report Number: 2017233-2019-00846
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623914
• UDI-Public: 00733132623914
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: VBJR051002A
• Device Lot Number: 20734298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR