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

Catalog Number VBH101502A

Device Problem Device Damaged by Another Device (2915)

Patient Problem Occlusion (1984)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.The device was not returned to the manufacturer.(b)(4).

Event Description

The following was reported to gore: the patient presented for a popliteal aneurysm case.Two gore® viabahn® endoprosthesis were placed successfully.During the deployment of the third gore® viabahn® endoprosthesis inside a previously implanted bare metal stent, the gore® viabahn® endoprosthesis partially expanded and then the deployment line snagged on the bare metal stent and broke.The doctor elected to leave the partially expanded gore® viabahn® endoprosthesis in place and perform a surgical bypass.The patient tolerated the procedure.The device remains in the patient.

Manufacturer Narrative

Additional manufacturer narrative: patient identifier, patient age, patient gender.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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; flagstaff, AZ ; 9285263030
• MDR Report Key: 7251409
• MDR Text Key: 99348111
• Report Number: 2017233-2018-00085
• Device Sequence Number: 1
• Product Code: PFV
• 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,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2020
• Device Catalogue Number: VBH101502A
• Device Lot Number: 17273859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2017
• 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: 78 YR