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

Catalog Number VBH131002A

Device Problem Entrapment of Device (1212)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: a review of the manufacturing records indicated that the device met pre-release specifications.(b)(4).

Event Description

The following was reported to gore: the gore® viabahn® endoprosthesis with heparin appeared to be stuck on the.035 super stiff wire before it entered the 12fr sheath.The gore® viabahn® endoprosthesis with heparin became stuck on the wire over the left external iliac.The doctor pulled back on the gore® viabahn® endoprosthesis with heparin and the sheath inadvertently came out of the patient.The decision was made to remove the device and wire simultaneously.As the gore® viabahn® endoprosthesis with heparin and wire were being removed, the distal end of the gore® viabahn® endoprosthesis with heparin caught on the preclose sutures that had been put in before the case as a means to stitch the artery closed.The gore® viabahn® endoprosthesis with heparin was removed but the patient lost a lot of blood transitioning to a larger sheath.The sheath was upsized to a 16fr sheath and another gore® viabahn® endoprosthesis with heparin was successfully placed.The doctor performed a cutdown to repair the puncture artery site.

Manufacturer Narrative

Examination of the returned device revealed the following: the endoprosthesis was compressed towards the tip end; approximately 3.8 cm of distal shaft, upon which the endoprosthesis is mounted, was exposed at the transition; approximately 0.2 cm of the outer braided constraining line was deployed near the transition; there was a circumferential row of bent struts nearest to the transition.This end of the endoprosthesis also had 2 blue knotted fibers stuck to the struts (the observed fibers are not part of a gore device, therefore were not evaluated).Based on the device examination performed, no manufacturing anomalies were identified.

• 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: 7431276
• MDR Text Key: 105511764
• Report Number: 2017233-2018-00217
• 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: 04/13/2018

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: 06/20/2019
• Device Catalogue Number: VBH131002A
• Device Lot Number: 15518232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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): Required Intervention