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

Catalog Number VBJR061002A

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem Vascular Dissection (3160)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi information: (b)(4).Results: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

On (b)(6) 1993 a patient underwent a coronary artery bypass graft procedure.On (b)(6) 2018 the patient underwent a revision of the coronary artery bypass procedure.Specifically the saphenous vein graft utilized in the bypass procedure had become dissected.The dissection was intended to be treated with a gore® viabahn® endoprosthesis.Access was obtained from the left common femoral artery.The device was advanced over an 8fr glide catheter through an 8fr.Sheath.When the device was advanced to the intended site (the saphenous vein graft of the right coronary artery), deployment was attempted, but was not possible.The deployment line was pulled but no device expansion occurred.The undeployed device was removed from the patient and the procedure was converted to an open repair.The patient tolerated the procedure.On either (b)(6) 2018 the patient expired.The viabahn was not considered a cause or contributing factor to the death.The device was used off label as a bail out in a complicated procedure in which the patient was not doing well.

• 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7532297
• MDR Text Key: 108853340
• Report Number: 2017233-2018-00292
• 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
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2019
• Device Catalogue Number: VBJR061002A
• Device Lot Number: 15697502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• 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): Hospitalization; Other; Required Intervention
• Patient Weight: 109