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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 07/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device could not be conducted because the lot number remains unknown.The device remains implanted, so no engineering evaluation could be performed.

Event Description

The study included 22 patients with single stent and antegrade flow configuration; they were divided in two groups (pre and post ¿over-sirix¿).¿over-sirix¿ was carried out in the retrospective group (pre ¿over-sirix¿) and it was used to plan the endovascular procedure in the prospective group (post ¿over-sirix¿).The most used chimney grafts (cg) association was tag/ctag (gore & associates, (b)(4)) and viabahn in 77% of cases.The results, including secondary endopoints, are the following: patient 11, for whom a reintervention was reported based on endoleak type i, also presented with one of the six reported bird beaks.The medical device was implanted within the left subclavian artery (lsa).It was stated that the reported endoleaks occurred in patients with big gutters area caused by a too low oversizing rate; reintervention was made in case of sac enlargement.The reported bird beaks occurred for the same reason and for radius of curvature.

• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6922786
• MDR Text Key: 88706765
• Report Number: 2017233-2017-00526
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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): Required Intervention
• Patient Age: 72 YR