MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24620

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/03/2021

Event Type  Injury  

Manufacturer Narrative

Age at time of enrollment: 56 years.Initial reporter facitily name: (b)(6).

Event Description

(b)(6) study: it was reported that instent re-occlusion occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2016, and the index procedure was performed on the same day.The target lesion was located in the right mid superficial femoral artery (sfa) with 100 % stenosis and was 125 mm long with a proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm and was classified as a tasc ii d lesion.Target lesion was treated with pre-dilation, placement of a 6.0 mm x 150 mm study imperial eluvia stent system.Following post-dilation residual stenosis was 0%.The subject was discharged on dual antiplatelet therapy.On (b)(6) 2021, 1614 days post-index procedure, the subject experienced right leg pain and coldness.On (b)(6) 2021, the subject presented to the emergency department with worsening right leg pain, especially in the toes and foot for the past two days.The subject had a previously unsuccessful fem-pop bypass bilaterally two years ago that had since failed.The subject was scheduled for computed tomography (ct) angiogram and recommended pain control.The ct angiogram with aorta ilio-femoral leg runoff revealed: extensive atherosclerosis noted throughout the iliac arteries, right external iliac artery with stent-graft completely occluded, bilateral sfa was completely occluded throughout the proximal and mid segments with some partial reconstitution of flow distally at above the adductor canals, right femoral/ popliteal artery bypass graft was completely occluded, moderate atherosclerosis and multifocal areas of mild to moderate stenosis in the calf, intact 3 vessels arterial runoff below the knee, bilaterally with intact dorsalis pedis.The subject did not have a life-threatening, injury, or end-organ damage requiring hospitalization for further treatment in the emergency department hence the subject was discharged with pain control medication with a planned procedure at a later date.On (b)(6) 2021, the subject was hospitalized due to worsening pre-existing right leg pain.On (b)(6) 2021, 1621 days post-index procedure, re-intervention in the right leg was performed.During the procedure, a fresh sub-acute thrombus was identified in the femoral artery which was consistent with his clinical history of 2 to 3 weeks of clotted graft.The site confirmed that thrombus was noted throughout the arteries in the right leg including the stents.Due to the posterior aspect of the graft replaced with a soft plaque which likely contributed to his graft failure, the graft itself was unroofed and arteriotomy was performed all way down to the proximal profunda.Proximal profunda was also found to be severely diseased, hence profundoplasty was extended till the first branch for adequate endarterectomy.Eversion endarterectomy was performed on the main profundal femoral branch and standard endarterectomy was performed on the other branches coming off laterally.The endarterectomy was continued until the right sfa.The endarterectomized surface was closed with 0.8 x 8 cm length bovine pericardial patch angioplasty.A doppler ultrasound (dus) performed revealed good flow in the lateral branch of the common femoral artery but not in the main profunda femoral branch with a little bit of flow sfa and wimpy pulse in the femoral artery.A repeat angiogram revealed the main outflow branch of the profundal femoral artery which appeared to be dissected from the endarterectomy that was previously performed in the main profunda branch.Right sfa had little flow and the lateral branch in the profunda filled nicely.High-grade stenosis of the external iliac artery (eia) from its origin to the last 3 or 4 cm of the stent in the eia was noted.Angioplasty with a 6 mm x 100 mm balloon was performed in the existing express stent in the eia to remove some intimal hyperplasia which resulted in a good pulse but did not have a very good patency rate.Hence, in addition, 6 mm x 57 mm and 6 mm x 37 mm non-boston scientific bare-metal stents were used in an overlapping manner distally to the express stent which was still patent in the distal region.Further dissection was performed in the profunda down to the main trunk of the profunda femoral artery exposing tertiary bifurcation of the main femoral trunk.Due to significant posterior plaque, an endarterectomy was performed on the back wall of the profunda and closure was achieved using another bovine pericardial patch.A repeat angiogram revealed good patency in both the lateral and main branches of profunda.Despite a large number of collaterals, the thigh did not opacify well.Bypass surgery was performed using reversed non-boston scientific alternative vascular prosthesis with proximal anastomosis at the right femoral artery to the distal anastomosis at the anterior tibial artery.The graft was arterialized and everything was noted to be hemostatic.A completion angiogram was performed which demonstrated wide patency of the bypass graft.Anterior tibial artery filled nicely, where the mild disease persisted proximally and retrograde through the posterior tibial artery.The iliac artery was noted to be widely patent and had good femoral as well as good graft pulse.The wounds were starting to become a little more hemostatic, so the subject received a cell saver as there was blood loss due to a long procedure.Fibrillar and protamine were used, and wounds were closed in layers with deep 3-0 monocryl sutures in multiple layers and interrupted 3-0 nylons for the skin of both incisions.The subject tolerated the procedure well and there were no complications and was taken back to recovery in good condition.Follow-up core-lab angiography on (b)(6) 2021, revealed: a grade 0 thrombus, absence of aneurysm, and isr stenosis pattern of 4.No evidence of stent deformation or stent fracture was noted.At the time of the report, the event was considered to be resolved.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14432062
• MDR Text Key: 292024049
• Report Number: 2134265-2022-05395
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018822230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: White