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

Catalog Number JHJR052502J

Device Problem Component Missing (2306)

Patient Problem Occlusion (1984)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) a review of the manufacturing records for the devices could not be performed as lot/serial numbers were unavailable.Per the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use, complications associated with the use of the gore® viabahn® endoprosthesis may include, but are not limited to stenosis, thrombosis, or occlusion.

Event Description

On (b)(6) 2018, the patient was implanted with two gore® viabahn® endoprosthesis with heparin bioactive surface (jhjr052502j/lot numbers unknown) to treat an occlusion of the right superficial femoral artery.On (b)(6) 2018, it was reported that the patient spent approximately three hours sitting down kneeling with the buttocks on top of the ankles.Afterward, the patient reportedly experienced leg pain.On (b)(6) 2018, it was confirmed that the endoprostheses were occluded.Claudication was also observed.The physician believed that the patient¿s prolonged kneeling position may have contributed to the occlusion.On the same day, thrombectomy of the right superficial femoral artery was performed to repair the occlusion.A procedural angiograph reportedly showed the issue was resolved.The patient tolerated the procedure.

• 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: damon jackson ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7625829
• MDR Text Key: 111905903
• Report Number: 2017233-2018-00331
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR052502J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention