MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 10/05/2018

Event Type  Injury  

Manufacturer Narrative

Since no patient id is available, the gore event number was used as the patient identifier.The patient age and patient gender reflect the mean age and gender stated in the article.The date of online publication was used as the event date.Lot/serial numbers were not provided, therefore, a review of the manufacturing records could not be conducted.

Event Description

The following publication was reviewed: ¿viabahn stent graft compared with prosthetic surgical above-knee bypass in treatment of superficial femoral artery disease¿ (narges waezi, medicine (2018) 97, published online 05-oct-2018).Records of 52 patients (60 limbs), who were treated by a prosthetic surgical above-knee bypass (pakb) (29 limbs) or gore viabahn® endoprosthesis (31 limbs) implantation in the superficial femoral artery between 2005 and 2011 were reviewed.In all patients, conservative therapy was maxed out.All patients suffered from chronic ischemia and were categorized by rutherford categories based on symptoms and clinical presentation at the time of the revascularization.The article includes the following cases in the viabahn group: among other reported stent graft failures, it was stated that two stent-graft failures occurred during the first month after implantation due to thrombosis.The article is not specific on how the two patients were treated.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• 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: joerg kersten ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9123117
• MDR Text Key: 164107204
• Report Number: 2017233-2019-00926
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2019
• 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: 68 YR