MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBCR071501A

Device Problem Insufficient Information (3190)

Patient Problems Fistula (1862); Hematoma (1884); Thrombosis (2100)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.(b)(4).

Event Description

The following was reported to gore: the patient presented with radiocephalic fistula; the gore® viabahn® endoprosthesis was inserted through the sheath over a wire across the lesion; the doctor inadvertently placed a portion of the gore® viabahn® endoprosthesis outside the vein; the gore® viabahn® endoprosthesis was deployed; hematoma and thrombosis occurred; patient was taken to hospital for ligation of fistula.Patient is stable.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 5698329
• MDR Text Key: 46568796
• Report Number: 2017233-2016-00550
• Device Sequence Number: 1
• Product Code: NIP
• 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: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Catalogue Number: VBCR071501A
• Device Lot Number: 12789867
• 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: 05/29/2014
• 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: 63 YR
• Patient Weight: 147