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

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device lot number information was requested, but not provided.Therefore, no review of the manufacturing paperwork could be performed.No device was returned.Therefore, direct product analysis was not possible.Instructions for use warnings section state, w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis with heparin bioactive surface in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.

Event Description

Reviewed was a poster summary publication, "use of viabahn endograft for repair of popliteal artery aneurysm: largest single center experience," abstract category: 18.Interventional cardiology: carotid and endovascular intervention presentation number: 1112-123; authors: shankho ganguli, tracy hammonds, tonga nfor, m.Fuad jan.This was an observational study of 68 patients (79 limbs) to determine primary patency in patients with popliteal artery aneurysm (paa) who underwent endovascular repair between 2011-2016.Males accounted for approximately 92% of the population with an average age of 73 years.The majority of subjects were smokers with hypertension.Operative characteristics include 45/55 stents crossing knee joints.Mean follow-up was 2.5 years.Index intervention for acute ischemia was predictive of 12-month post-operative stenosis (p =.017).Outcomes show primary patency rate as 73.4%, and the 12-month patency rate at 91.1% (72/79 limbs).12-month intervention rate was 7 out of 79 limbs.All interventions were not listed.However, one stent fracture (1/79) was reported.The study did not include information on how the stent fracture was confirmed nor did it provide information about the type of intervention.

Manufacturer Narrative

For all patients, reason for treatment and post-operative medications were added.Street address was updated.

Manufacturer Narrative

Updated information was received and we are withdrawing the report previously submitted.It was reported that the physician/author stated it was not a gore® viabahn® endoprosthesis that fractured, contrary to what was indicated in the article.Rather, a different stent that was implanted at another time.The physician indicated he plans to revise the publication.

Event Description

Updated information: it was reported that the physician/ author stated it was not a gore® viabahn® endoprosthesis that fractured, contrary to what was indicated in the article.Rather, a different stent that was implanted at another time.The physician indicated he plans to revise the publication.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6909670
• MDR Text Key: 89507233
• Report Number: 2017233-2017-00517
• 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,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/03/2017; 10/23/2017
• 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