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

Device Problems Material Invagination (1336); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Article citation: title: four-year outcomes following endovascular repair in patients with traumatic isolated popliteal artery injuries.Chuli jiang, et al.Https://doi.Org/10.1016/j.Jvs.2020.12.050.Journal of vascular surgery.Volume 73, issue 6, june 2021, pages 2064-2070.Patient weight was unavailable.Implant date was unavailable.Patient demographics: provided mean age was 51 years old and gender of article is 70% male, 30% female.Patient information will reflect 51-year-old male.A review of the manufacturing records for the device was unable to be conducted as no lot number was available.The device was not accessible for testing, therefore, the device was not able to be evaluated.It is unknown if these adverse events were related to the viabahn devices.Information was not made available.Cause of the event cannot be established based on the available information.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following information was received through literature ¿four-year outcomes following endovascular repair in patients with traumatic isolated popliteal artery injuries¿ published in journal of vascular surgery in 2021.This study was aimed to investigate the midterm outcomes of endovascular repair of traumatic isolated popliteal arterial injury.From (b)(6) 2012 to (b)(6) 2020, 46 patients who underwent endovascular repair using viabahn devices for traumatic popliteal arterial injuries were reviewed.The patients were mainly in traffic accidents and had traumatic injuries.Conclusion: endovascular repair of an isolated popliteal artery injury may be a safe and effective alternative treatment in select patients, with acceptable midterm outcomes.5 patients required below-knee amputation owing to irreversible ischemia within 48 hours after endovascular treatment.All of them had class iii acute limb ischemia and a long time interval from trauma to blood flow restoration (>20 hours).6 patients had graft occlusion and underwent reintervention within 30 days.All of them had combined tibial plateau or distal femoral fracture.After endovascular repair, open reduction and internal fixation was performed, and ischemic symptoms developed within 14 days after the orthopedic surgery.The patients were treated with catheter-directed thrombolysis because of intrastent thromboses.One received balloon angioplasty and inline stenting owing to an in-folding stent graft.The symptoms resolved successfully after reintervention in all patients.

Manufacturer Narrative

B1: add product problem.

Event Description

The following information was received through literature ¿four-year outcomes following endovascular repair in patients with traumatic isolated popliteal artery injuries¿ published in journal of vascular surgery in 2021.This study was aimed to investigate the midterm outcomes of endovascular repair of traumatic isolated popliteal arterial injury.From january 2012 to february 2020, 46 patients who underwent endovascular repair using viabahn devices for traumatic popliteal arterial injuries were reviewed.The patients were mainly in traffic accidents and had traumatic injuries.Conclusion: endovascular repair of an isolated popliteal artery injury may be a safe and effective alternative treatment in select patients, with acceptable midterm outcomes.5 patients required below-knee amputation owing to irreversible ischemia within 48 hours after endovascular treatment.All of them had class iii acute limb ischemia and a long time interval from trauma to blood flow restoration (>20 hours).6 patients had graft occlusion and underwent reintervention within 30 days.All of them had combined tibial plateau or distal femoral fracture.After endovascular repair, open reduction and internal fixation was performed, and ischemic symptoms developed within 14 days after the orthopedic surgery.The patients were treated with catheter-directed thrombolysis because of intrastent thromboses.One received balloon angioplasty and inline stenting owing to an in-folding stent graft.The symptoms resolved successfully after reintervention in all patients.Including the 6 patients mentioned, a total of 15 patients required reoperation (1 had femorotibial artery bypass, 14 had balloon angioplasty, thrombolysis, and additional stenting) to treat stent graft thrombosis or in-folding during follow-up (36.1 months).5 of them presented with subacute or chronic ischemia within 6 to 9 months after endovascular reintervention and they received a third intervention (one patient with stent graft thrombosis had balloon angioplasty and thrombolysis, in-folding stent graft was identified in four patient, who had bypass surgery and blood flow was restored successfully).Only those requiring reoperation as a result of the alleged in-folding are reportable, but the number of patients is unknown.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15230975
• MDR Text Key: 297953726
• Report Number: 2017233-2022-03213
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 09/03/2022; 09/03/2022
• Supplement Dates FDA Received: 09/08/2022; 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male