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

Catalog Number VBJR050502A

Device Problem Material Distortion (2977)

Patient Problem Fistula (1862)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Warnings in gore viabahn endoprosthesis ifu states: w.L.Gore & associates has insufficient clinical and experimental data regarding the use of the gore viabahn endoprosthesis within stents or stent grafts (other than the gore viabahn endoprosthesis with heparin bioactive surface or the gore viabahn endoprosthesis) that have been implanted for less than 30 days.Other devices implanted for less than 30 days may interfere with the deployment of the gore viabahn endoprosthesis resulting in deployment failure or other device malfunctions.

Event Description

On (b)(6) 2015, a patient with highly calcified vessels underwent an endovascular procedure to treat an occluded common femoral and superficial femoral artery.The target lesions were accessed from the popliteal artery.A supera stent was placed in the common femoral artery.Lifestents were deployed in the superficial femoral artery.On (b)(6) 2015, the patient presented with a very large fistula at the access site in the popliteal artery.To repair the fistula, access was gained from contralateral leg, up and over the bifurcation.A sheath was used to advance the gore viabahn endoprosthesis through the stents implanted the day before.The gore viabahn endoprosthesis was advanced about half way through the stents when the gore viabahn endoprosthesis got hung up.Under fluoroscopy, it appeared that the tip of the gore viabahn endoprosthesis was expanding.Since the device and deployment line could not be retracted, a decision was made to deploy the gore viabahn endoprosthesis at its current location.The gore viabahn endoprosthesis was deployed but appeared distorted with the deployment line tangled around the distal portion of the device.Imaging also showed the radiopaque markers were sideways, into the left side of the image.In order to open the gore viabahn endoprosthesis, the proximal end of gore viabahn endoprosthesis was cannulated.Using the back end of a stiff guidewire and an expanded 5mm balloon, the device was opened close to the distal tip.The distal tip of the device was then cannulated with a wire, balloon was advanced and inflated, achieving full expansion of the gore viabahn endoprosthesis.To complete the procedure, a 90cm 8fr sheath was advanced beyond the previously implanted stents.A gore viabahn endoprosthesis was advanced and deployed, covering the fistula.

Manufacturer Narrative

Was corrected to 'yes'.Device remains in patient.Deployment line and delivery catheter were returned for evaluation.Evaluation was included in initial manufacturer report.

Manufacturer Narrative

(b)(4).

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5316327
• MDR Text Key: 34055160
• Report Number: 2017233-2015-00905
• 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,Followup,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2017
• Device Catalogue Number: VBJR050502A
• Device Lot Number: 13054699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2014
• 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: 94 YR