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

Catalog Number JHJR081002J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

Due to an unknown lot/serial number and no device return, an investigation could not be performed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following publishment was reviewed by gore: title: late vascular injury at both edges of the viabahn stent graft after endovascular repair for idiopathic superficial femoral artery rupture source: ann vasc dis vol.14, no.2; 2021; pp 173¿176.A (b)(6) asian woman was admitted to the emergency room at our institution due to exacerbating pain in the right thigh and swelling 2 days back.Two months prior to admission, the patient reportedly underwent patch-closure surgery for a ruptured sinus of valsalva and re-surgery for re-rupture of the sinus of valsalva after 1 month (aortic valve replacement [mechanical valve] and tricuspid valve repair).The patient was taking warfarin after cardiac surgery.The patient¿s level of consciousness was found to be normal, and she was not in a state of shock.Significant swelling and pain in the right thigh were observed.However, no signs of infection were noted, and there was no ischemia in the right lower extremity.Blood examination findings upon admission were as follows: white blood cell count, 7350/l; c-reactive protein level, 5.23 mg/dl; and procalcitonin level, 0.21 ng/ml.As per her contrastenhanced computed tomography (ct) scans, a giant pseudoaneurysm (with a diameter of 10 cm) was found in her right thigh with extravasation from the main trunk of the distal sfa.A shift and lumen narrowing of the sfa due to pseudoaneurysm displacement were observed.The three tibial vessels were clearly visible.The patient was then diagnosed with sfa rupture and immediately underwent surgery using the endovascular stent graft approach.A 7-fr sheath was placed into the right sfa with a right common femoral artery antegrade puncture.A 0.018-in stiff wire was cannulated into the below-the-knee artery, and the viabahn (self-expanding type, 8 mm×10 cm) stent graft was placed, without predilatation, from the distal sfa (internal diameter: 7.3 mm) to the above-the-knee popliteal artery (internal diameter: 7.1 mm) superior to the patella.Angiography revealed the successful exclusion of the pseudoaneurysm and good peripheral blood flow without postdilatation.The postoperative course was deemed favorable.Aspirin was administered, and the patient was discharged 13 days after endovascular treatment.Ct at 19 days after endovascular treatment revealed that the hematoma size had reduced, and the stent graft was patent.Ultrasonography at 3 months after the endovascular treatment revealed the same findings.However, 125 days after endovascular treatment, the patient was admitted to the department of cardiovascular surgery due to congestive heart failure.She experienced pain behind the right knee after hospitalization, and ct at 137 days after endovascular treatment revealed the presence of pseudoaneurysms (2203-a:-other) at both edges of the stent graft.There were no findings indicating the presence of an infection or ischemia in the right lower extremity.The patient underwent emergent hybrid surgery, which comprised the following: prosthetic graft bypass (gore® propaten® integrated ring, 8 mm) from the middle sfa to the below-the-knee popliteal artery, embolization of the behind-the-knee popliteal artery (amplatzer vascular plug ii®, 14 mm), embolization of the proximal edge of the stent graft (amplatzer vascular plug ii®, 14 mm), and ligation of the sfa at the peripheral area of the proximal graft anastomosis.The middle sfa and the below-the-knee popliteal artery, the regions of anastomosis, were moderately sclerotic, and pseudoaneurysm thrombosis and good peripheral blood flow were observed.Antibiotics were administered 5 days after the surgery.The patient was discharged after the treatment of congestive heart failure.Ten months after the lower extremity bypass, the hematoma size was noted to decrease, the bypass was patent, and there were no signs of infection.Moreover, no new vessel ruptures were observed, including that in the area of the anastomosis.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12741692
• MDR Text Key: 280094494
• Report Number: 2017233-2021-02507
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2021

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
• Device Catalogue Number: JHJR081002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR