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

Device Problems Failure to Advance (2524); Torn Material (3024)

Patient Problems Fall (1848); Pseudoaneurysm (2605)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

Additional device: gore® viabahn® endoprosthesis unknown size, unknown lot number.Lot/serial numbers were not provided, therefore, a review of the manufacturing records could not be conducted.If lot/serial numbers are obtained, the review will be included on the final report.

Event Description

On an unknown date several years ago, a patient underwent treatment of a right superficial femoral artery lesion with two gore® viabahn® endoprosthesis.Some time prior to (b)(6) 2017 the patient, who is also a bicyclist, fell.Following the fall, images revealed the viabahn stents appeared to be torn.A pseudoaneurysm was also noted.On (b)(6) 2017 the patient underwent a reintervention with a plan to reline the originally placed viabahn devices.However, when attempts were made to advance a wire to these devices, it was not possible to do so, as the devices were offset.The procedure was ended with a plan to refer the patient for an open bypass procedure.There is no plan to explant the viabahns.The patient is doing well currently.

Manufacturer Narrative

The imaging evaluation stated the following: the images provided do not allow for evaluation in relationship to this event.

Manufacturer Narrative

Results code: updated imaging evaluation: there appears to be a pseudo aneurysm present.There appears to gap/space between the device, unable to confirm separation or two separate devices with available image set.Images received via (email) with no patient identifier or date of acquisition in image.Images can not able to be manipulated in anyway, lengths and diameter cannot be measured with available image.

• 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6430149
• MDR Text Key: 70740924
• Report Number: 2017233-2017-00146
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 60 YR