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

Device Problem Complete Blockage (1094)

Patient Problems Ischemia (1942); Occlusion (1984)

Event Date 03/27/2019

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 reflects 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: ¿long-term results of the heparin-bonded viabahn stent graft in femoropopliteal tasc c and d lesions with a covered stent length of minimum 25 cm¿ (c.Uhl et.Al, vacular, 2019, published online 27-mar-2019).The article analyzed the outcome of 62 patients that presented with femoropopliteal tasc c or d lesions that were treated with gore viabahn® endoprostheses with a minimum length of 25cm between july 2010 and march 2018.It was also stated that in 37 cases, one stent graft was used, and in the other 23 cases more than one stent graft was necessary.The used stent diameter was between 5 mm and 8 mm.The article includes the following case: for one patient an early occlusion occurred (<30days) in which the patient underwent major amputation without further revascularization treatment.Indication in this case was critical limb ischemia in a patient additionally suffering from a bowel cancer under palliative care.Because of the high intestinal bleeding risk, a lysis was not feasible to treat the graft occlusion.Autologous vein was also not available in this patient.Due to the increasing necrosis of the foot, we decided for major amputation.

• 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: 9108776
• MDR Text Key: 161512936
• Report Number: 2017233-2019-00892
• 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: 09/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: 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