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

Model Number 24657

Device Problem Fracture (1260)

Patient Problems Pain (1994); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 03/02/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: (b)(6).

Event Description

(b)(4) clinical trial: it was reported this stent had restenosis and internal device fracture.The subject underwent treatment with the 6.0mm x 100mm eluvia drug eluting stent on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was located in the right distal superficial femoral artery (sfa) with proximal reference vessel diameter of 5mm and distal reference vessel diameter of 5mm.The lesion was 100mm long , 100% stenosed, and classified as tasc ii b lesion.Prior to target lesion treatment, pre dilation was performed using a 5mm x 150mm mustang percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was performed by implanting a 6.0mm x 100mm eluvia, and the residual stenosis was noted to be 0%.The patient was discharged the same day on clopidogrel.During treatment of the target lesion, dissection of grade b was noted post angioplasty with 5 mm x 150 mm mustang balloon.In response to the event 6.0 mm x 100 mm eluvia stent was implanted.Following post dilatation with 5.0 mm x 150 mm mustang pta balloon, the final residual stenosis was noted to be 0%.The complication was resolved.On (b)(6) 2022, the subject presented with the symptoms of worsened pain of bilateral calves (right leg worse than left).On the same day, ankle brachial indices at rest were measured which revealed right 0.61 and left 0.86.Toe brachial indices at rest revealed right 0.58 and left 0.81, and absolute great toe pressure at rest were right 81 mmhg and left 113 mmhg.The ankle pulse volume recording waveforms were of moderately abnormal amplitude on the right and mildly abnormal amplitude with bunted dicrotic notch on the left.There was dampened flow in all five right five digits and dampened flow in all the left digits by photoplethysmography.An additional vascular evaluation revealed monophasic doppler signal of right posterior tibial and peroneal artery; no wounds or ulcers were noted.On (b)(6) 2022, the subject revisited the hospital for planned lower extremity arteriogram which revealed the right sfa was occluded from the ostium.The stent was occluded and fractured.No additional intervention had been performed at this time, however bypass surgery was recommended at a later date.

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: 66 years.

Event Description

Elegance clinical trial it was reported this stent had restenosis and internal device fracture.The subject underwent treatment with the 6.0mm x 100mm eluvia drug eluting stent on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was located in the right distal superficial femoral artery (sfa) with proximal reference vessel diameter of 5mm and distal reference vessel diameter of 5mm.The lesion was 100mm long , 100% stenosed, and classified as tasc ii b lesion.Prior to target lesion treatment, pre dilation was performed using a 5mm x 150mm mustang percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was performed by implanting a 6.0mm x 100mm eluvia, and the residual stenosis was noted to be 0%.The patient was discharged the same day on clopidogrel.During treatment of the target lesion, dissection of grade b was noted post angioplasty with 5 mm x 150 mm mustang balloon.In response to the event 6.0 mm x 100 mm eluvia stent was implanted.Following post dilatation with 5.0 mm x 150 mm mustang pta balloon, the final residual stenosis was noted to be 0%.The complication was resolved.On (b)(6) 2022, the subject presented with the symptoms of worsened pain of bilateral calves (right leg worse than left).On the same day, ankle brachial indices at rest were measured which revealed right 0.61 and left 0.86.Toe brachial indices at rest revealed right 0.58 and left 0.81, and absolute great toe pressure at rest were right 81 mmhg and left 113 mmhg.The ankle pulse volume recording waveforms were of moderately abnormal amplitude on the right and mildly abnormal amplitude with bunted dicrotic notch on the left.There was dampened flow in all five right five digits and dampened flow in all the left digits by photoplethysmography.An additional vascular evaluation revealed monophasic doppler signal of right posterior tibial and peroneal artery; no wounds or ulcers were noted.On (b)(6) 2022, the subject revisited the hospital for planned lower extremity arteriogram which revealed the right sfa was occluded from the ostium.The stent was occluded and fractured.No additional intervention had been performed at this time, however bypass surgery was recommended at a later date.It was further reported that on (b)(6) 2022, the subject revisited the hospital for the planned bypass surgery and was hospitalized on the same day for further medical intervention due to target lesion restenosis.The lesion was treated by performing right femoral to popliteal artery bypass surgery.

Manufacturer Narrative

A1 - patient identifier: (b)(4).A2 - age at time of event: patient was 66 years at time of study enrollment.

Event Description

Elegance clinical trial it was reported this stent had restenosis and internal device fracture.The subject underwent treatment with the 6.0mm x 100mm eluvia drug eluting stent on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was located in the right distal superficial artery with proximal reference vessel diameter of 5mm and distal reference vessel diameter of 5mm.The lesion was 100mm long , 100% stenosed, and classified as tasc ii b lesion.Prior to target lesion treatment, pre dilation was performed using a 5mm x 150mm mustang percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was performed by implanting a 6.0mm x 100mm eluvia, and the residual stenosis was noted to be 0%.The patient was discharged the same day on clopidogrel.On (b)(6) 2022, the subject presented with the symptoms of worsened pain of bilateral calves (right leg worse than left).On the same day, ankle brachial indices at rest were measured which revealed right 0.61 and left 0.86.Toe brachial indices at rest revealed right 0.58 and left 0.81, and absolute great toe pressure at rest were right 81 mmhg and left 113 mmhg.The ankle pulse volume recording waveforms were of moderately abnormal amplitude on the right and mildly abnormal amplitude with bunted dicrotic notch on the left.There was dampened flow in all five right five digits and dampened flow in all the left digits by photoplethysmography.An additional vascular evaluation revealed monophasic doppler signal of right posterior tibial and peroneal artery; no wounds or ulcers were noted.On (b)(6) 2022, the subject revisited the hospital for planned lower extremity arteriogram which revealed the right common iliac artery had mild non-flow limiting stenosis, the right anterior tibial artery was diffusely diseased and diminutive in the distal calf, the right tibioperoneal trunk artery had mild to moderate stenosis, and the right superficial femoral artery (sfa) was occluded from ostium.The site reported a stent fracture and occlusion of the study device.No additional intervention had been performed at this time, however bypass surgery was recommended at a later date.It was further reported that on (b)(6) 2022, the subject revisited the hospital for the planned bypass surgery and was hospitalized on the same day for further medical intervention due to target lesion restenosis.The lesion was treated by performing right femoral to popliteal artery bypass surgery.If was further reported that on the same day of index procedure, 70% stenosis noted in the right external iliac artery was treated with 7 mmx 40 mm balloon followed by placement of 8 mm x 40 mm self-expanding stent.Subsequently, high-grade stenosis noted in the left external iliac artery was treated with 7 mm x 40 mm balloon and 8 mm x 40 mm self-expanding stent.Post treatment, no residual stenosis was noted.On (b)(6) 2022, subject visited the hospital as follow-up of the symptoms of claudication that occurred after ambulating short distance and was lifestyle limiting.Subject continued to have right leg pain worse than the left leg.No evidence of rest pain or wounds/ulcers were noted, and rutherford category was assessed as 3.Subject was also noted with soreness in the hips which was likely musculoskeletal in nature and did not align with the blockage found on angiogram.Based on the findings from the study results and arteriogram, subject was recommended to undergo right femoral to popliteal graft in mid-april.Subject was instructed to ambulate 5 days a week and to continue aspirin.On (b)(6) 2022, subject was scheduled for right femoral to above knee popliteal bypass surgery, however, subject had developed groin folliculitis bilaterally and the procedure was not performed.Subject was sent home with doxycycline and the right femoral to above knee popliteal bypass surgery was rescheduled on (b)(6) 2022.On (b)(6) 2022, the subject visited the hospital for the planned bypass surgery and was hospitalized on the same day for further medical intervention.On (b)(6) 2022, 185 days post index procedure, 100% stenosis noted in the superficial femoral artery was treated by performing right femoral to above knee popliteal artery bypass surgery with 8 mm fusion bioline graft.In addition, endarterectomy of common femoral artery was performed using freer elevator during the procedure.On (b)(6) 2022, the event was considered resolved and on the same day, the subject was discharged from the hospital.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14115904
• MDR Text Key: 289319925
• Report Number: 2134265-2022-03571
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• 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,Followup,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027593574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: White