MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM 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 Problems Ischemia (1942); Necrosis (1971); Neuropathy (1983); Pain (1994); Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 06/07/2021

Event Type  Injury  

Event Description

It was reported that the stent occluded, and the patient was diagnosed with critical right limb ischemia.The subject was enrolled in the (b)(6) study (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) extending to proximal popliteal artery with 100 % stenosis.The target lesion was 130 mm long with a proximal reference vessel diameter of 5.0 mm and a distal vessel diameter of 5.0 mm.It was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation with placement of a 6.0 mm x 150 mm study stent.Following post dilation residual stenosis was 20%.The subject was discharged on dual antiplatelet therapy.On (b)(6) 2021, 1657 days post index procedure, the subject was noted with critical right limb ischemia.On (b)(6) 2021, the subject was admitted for an angiogram.However, the procedure was cancelled and was rescheduled for next week due to marked anemia with h/h of 6.8/20.8 and platelet-37, for which 2 units of prbc was transfused.During the visit, the subject had also been evaluated for non-healing wound and cellulites for which iv antibiotics was administered.On (b)(6) 2021, the subject visited the hospital for planned selective angiography of the right lower extremity which revealed: diffused 50% irregular disease in right common femoral artery, mild plaquing in right profunda femoris, occluded stent in right sfa extending from proximal segment to till pe 1 segment of popliteal artery, occluded right popliteal artery, occluded tibioperoneal trunk and peroneal artery, and occluded posterior tibial artery in the distal calf level.From the level of ankle below, there was no flow noted in the right foot.In response to these findings, an attempt was made to revascularize the right sfa and popliteal artery.However, accessing the occluded right sfa and popliteal artery was unsuccessful, and hemostasis was achieved using manual compression after administration of protamine.Hence, based on the severity, it was decided that subject has no good revascularization options and was recommended for right above the knee amputation.On (b)(6) 2021, the subject visited hospital for planned above the knee amputation and had developed gangrene of the 5th toe with worsened ischemic changes and severe rest pain (rutherford category 5).Subsequently, the subject was hospitalized for further medical treatment.Occlusion of the right lower extremity was treated with above the knee amputation and medications were prescribed.The event was considered recovered/ resolved.On (b)(6) 2021, the subject was discharged on aspirin to rehab facility for further improvement strength and ability.

Event Description

It was reported that the stent occluded, and the patient was diagnosed with critical right limb ischemia.The subject was enrolled in the imperial study (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) extending to proximal popliteal artery with 100 % stenosis.The target lesion was 130 mm long with a proximal reference vessel diameter of 5.0 mm and a distal vessel diameter of 5.0 mm.It was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation with placement of a 6.0 mm x 150 mm study stent.Following post dilation residual stenosis was 20%.The subject was discharged on dual antiplatelet therapy.On (b)(6) 2021, 1657 days post index procedure, the subject was noted with critical right limb ischemia.On (b)(6) 2021, the subject was admitted for an angiogram.However, the procedure was cancelled and was rescheduled for next week due to marked anemia with h/h of 6.8/20.8 and platelet-37, for which 2 units of prbc was transfused.During the visit, the subject had also been evaluated for non-healing wound and cellulites for which iv antibiotics was administered.On (b)(6) 2021, the subject visited the hospital for planned selective angiography of the right lower extremity which revealed: diffused 50% irregular disease in right common femoral artery, mild plaquing in right profunda femoris, occluded stent in right sfa extending from proximal segment to till pe 1 segment of popliteal artery, occluded right popliteal artery, occluded tibioperoneal trunk and peroneal artery, and occluded posterior tibial artery in the distal calf level.From the level of ankle below, there was no flow noted in the right foot.In response to these findings, an attempt was made to revascularize the right sfa and popliteal artery.However, accessing the occluded right sfa and popliteal artery was unsuccessful, and hemostasis was achieved using manual compression after administration of protamine.Hence, based on the severity, it was decided that subject has no good revascularization options and was recommended for right above the knee amputation.On (b)(6) 2021, the subject visited hospital for planned above the knee amputation and had developed gangrene of the 5th toe with worsened ischemic changes and severe rest pain (rutherford category 5).Subsequently, the subject was hospitalized for further medical treatment.Occlusion of the right lower extremity was treated with above the knee amputation and medications were prescribed.The event was considered recovered/ resolved.On (b)(6) 2021, the subject was discharged on aspirin to rehab facility for further improvement strength and ability.It was further reported that on (b)(6) 2021, the subject visited the emergency department of hospital with complaints of worsening foot wound in the right fifth toe, which was gradually developing over the last 2 months.On examination, subject had 1 cm ulcerated wound, with surrounding edema, erythema, tenderness, and concern for gangrene.No purulent drainage was noted.On presenting to the emergency department, the subject was noted with peripheral neuropathy and complained of mild discomfort.Lab results during emergency department assessment showed normal white blood cells count and decreased absolute lymphocytes.X-ray was performed on the same day, which did not show any signs of osteomyelitis.On the same day, the subject was initiated with antibiotics amoxicillin-clavulanate (augmentin).No further action was taken at this point of time and subject was referred to other hospital for further management.It was further clarified that the subject was admitted for angiogram on (b)(6) 2021.On (b)(6) 2021, lab results showed normal white blood cells count.On the same day, the subject was discharged home and was advised to continue with the augmentin therapy and procedure was rescheduled for next week.On (b)(6) 2021, follow-up core-lab angiography findings noted grade 0 thrombus, absence of aneurysm and presence of isr stenosis pattern 4.No evidence of stent deformation or stent fracture was noted.On (b)(6) 2021, upon examination post procedure, incision was noted to be healing well and skin edges were viable.The subject was advised to continue using shrink stock/stump protector and tylenol was prescribed for pain control.

• Brand Name: ELUVIATM 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
• MDR Report Key: 12178737
• MDR Text Key: 261897742
• Report Number: 2134265-2021-09050
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• 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: 0018822232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention