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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/15/2008

Event Type  Injury  

Event Description

An article in the journal of vascular surgery (2015, in press) (¿a multicenter experience with the surgical treatment of infected abdominal aortic endografts,¿ authors -victor j.Davila, md, william stone, md, audra a.Duncan, md, emily wood, md, william d.Jordan jr, md, nicholas zea, md, w.Charles sternbergh iii, md, and samuel r.Money, md, mba,) reports a retrospective analysis of thirty-six patients treated with endovascular graft excision and revascularization for aortic endovascular graft infection (i-evar) at four institutions from 1997 to 2014.This article reports a gore® viabahn® endoprosthesis was implanted in one patient.It was alleged the gore® viabahn® endoprosthesis became infected and was explanted.

Manufacturer Narrative

Date of event is estimated to be (b)(6) 2015 because the publication date is reported to be 2015.No testing performed (no lot number reported).No results available since no evaluation performed.

Manufacturer Narrative

Additional information: other relevant history, including preexisting medical conditions: hypertension, tobacco use, coronary artery disease, lipid, steroid, copd, chronic renal failure if implanted, give date- (b)(6) 2008; if explanted, give date - (b)(6) 2008.Correction: age: (b)(6), date of event - (b)(6) 2008.

• 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 86001
• Manufacturer Contact: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4953253
• MDR Text Key: 17694621
• Report Number: 2017233-2015-00477
• 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: Literature,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• 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?: No
• 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: 71 YR