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

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problems Fistula (1862); Pain (1994); Thrombosis (2100); Urinary Tract Infection (2120); Stenosis (2263); Cancer (3262)

Event Date 01/12/2016

Event Type  Injury  

Manufacturer Narrative

No lot number information was supplied; therefore, no review of the manufacturing record history could be performed.The device was not returned.Therefore, direct product analysis was not possible.

Event Description

Information was received from an accepted, unpublished manuscript, liang nl, avgerinos ed, hager es, singh mj, endovascular repair of an iliac ureteroarterial fistula with late stent thrombosis and migration into the bladder, annals of vascular surgery (2016), doi: (b)(4).A (b)(6) year-old female patient complained of several weeks of rest pain in the right lower extremity with no palpable pulses on physical exam, as well as intermittent hematuria.An arteriogram showed diffuse high-grade stenosis of the common and external iliac arteries below the preexisting stent.Angiography after balloon angioplasty of this segment showed active extravasation of contrast into the dilated ureter and bladder, leading to a diagnosis of arterioureteral fistula.A gore(tm) viabahn(tm) endoprosthesis was placed in the iliac artery to exclude the fistula, with complete resolution of the patient's rest pain and hematuria postoperatively.The indwelling ureteral stents were removed and percutaneous nephrostomy tubes inserted.The patient did well and was discharged from the hospital on therapeutic anticoagulation, resumed due to her history of ipsilateral stent thrombosis.Approximately one year later, the patient was readmitted with insidious 2 onset of right lower extremity rest pain.Duplex ultrasound showed occlusion of the gore(tm) viabahn(tm) endoprosthesis and ipsilateral common and external iliac arteries despite the patient being continuously therapeutic on warfarin.An extra-anatomic right-to-left femoral-femoral bypass graft was then constructed with successful restoration of distal perfusion and resolution of her rest pain.Six months after placement of the fem-fem bypass, patient remained asymptomatic except for chronic recurrent urinary tract infections.A surveillance pet-ct of the abdomen and pelvis revealed migration of the thrombosed gore(tm) viabahn(tm) endoprosthesis through the dilated ureter into the bladder, as well as recurrent cervical cancer.After urologic and gynecologic consultation, cystoscopy and removal were not attempted due to the anticipated morbidity of any extraction procedure, the asymptomatic course of the indwelling stent, and poor prognosis of her recurrent cancer.Patient instead underwent bilateral ureteral occlusion for complete urinary diversion and was discharged from the hospital with close follow-up.

Manufacturer Narrative

Initial reporter address was updated with street address.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5737181
• MDR Text Key: 47792086
• Report Number: 2017233-2016-00592
• 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,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• 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: 37 YR