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

Model Number 24653

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

Patient Problems Ischemia (1942); Occlusion (1984); Reocclusion (1985); Pain (1994)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that an occlusion of the left leg occurred.The patient underwent treatment with the eluvia device on (b)(6) 2019 as part of the eminent clinical trial.The target lesion, located in the left mid superficial femoral artery (sfa), had 5.5 mm and 6 mm reference vessel diameter (distally and proximally) and was crossed subintimal.The lesion was 160 mm long and had 100% stenosis.Pre-dilatation was performed with two balloons, after which a 7 x 120 mm eluvia stent and a 7 x 60 mm eluvia stent were implanted.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2019, occlusion of the left sfa was observed and noted to be restenosis with multiple small thrombi in the study stent.It was treated with rotational thrombectomy on (b)(6) 2019.Treatment also included extension of the implanted eluvia stent with a 6 x 100 non-bsc stent and dilatation with a bare balloon.The event is reported as resolved as of june 14, 2019.

Event Description

It was reported that an occlusion of the left leg occurred.The patient underwent treatment with the eluvia device on (b)(6) 2019 as part of the eminent clinical trial.The target lesion, located in the left mid superficial femoral artery (sfa), had 5.5mm and 6mm reference vessel diameter (distally and proximally) and was crossed subintimal.The lesion was 160mm long and had 100% stenosis.Pre-dilatation was performed with two balloons, after which a 7x120mm eluvia stent and a 7x60mm eluvia stent were implanted.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2019, occlusion of the left sfa was observed and noted to be restenosis with multiple small thrombi in the study stent.It was treated with rotational thrombectomy on (b)(6) 2019.Treatment also included extension of the implanted eluvia stent with a 6x100 non-bsc stent and dilatation with a bare balloon.The event is reported as resolved as of (b)(6) 2019.Additional information reported that on (b)(6) 2019, the patient presented emergently due to sudden onset of weight bearing pain in left calf which was noted over past five days ago.Per source, the left foot was noted to be considerably cooler due to ischemia.The patient was hospitalized for further evaluation and treatment.At the time of admission, abi on the right was 0.8 and abi on left was 0.53.On (b)(6) 2019, angiography of left limb revealed occlusion of left sfa and posterior tibial artery.Additional event core lab angiography revealed patent inflow and outflow.However, occlusive isr pattern was noted with presence of thrombus and absence of aneurysm.On the same day, 100% stenosis with 370 mm long in the target lesion with 5 mm reference vessel diameter of 5 mm was thrombolysed rotationally using 6f-rotarex system repeatedly.Post thrombectomy, stent was extended proximally with 6 mm x 100mm ivolution stent.Post-dilation was performed using 5 mm x 120 mm pacific balloon and dilatation of popliteal artery was continued from pii up to pi segment with the same balloon.Due to in-stent residual stenosis, pronounced dissection was noted.Hence, extension of the stent implantation up to p2 with 5.5 mm x 80 mm supera stent was performed.Post treatment, residual stenosis was 10%.Pre-discharge abi on the left was 1.06.On (b)(6) 2019, the event was considered recovered/resolved and the patient was discharged on aspirin and plavix in a good general condition.

Manufacturer Narrative

Initial reporter address: (b)(6).

Manufacturer Narrative

Initial reporter address: (b)(6).

Event Description

It was reported that an occlusion of the left leg occurred.The patient underwent treatment with the eluvia device on (b)(6) 2019 as part of the eminent clinical trial.The target lesion, located in the left mid superficial femoral artery (sfa), had 5.5mm and 6mm reference vessel diameter (distally and proximally) and was crossed subintimal.The lesion was 160mm long and had 100% stenosis.Pre-dilatation was performed with two balloons, after which a 7x120mm eluvia stent and a 7x60mm eluvia stent were implanted.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2019, occlusion of the left sfa was observed and noted to be restenosis with multiple small thrombi in the study stent.It was treated with rotational thrombectomy on (b)(6)2019.Treatment also included extension of the implanted eluvia stent with a 6x100 non-bsc stent and dilatation with a bare balloon.The event is reported as resolved as of (b)(6) 2019.Additional information reported that on (b)(6) 2019, the patient presented emergently due to sudden onset of weight bearing pain in left calf which was noted over past five days ago.Per source, the left foot was noted to be considerably cooler due to ischemia.The patient was hospitalized for further evaluation and treatment.At the time of admission, abi on the right was 0.8 and abi on left was 0.53.On (b)(6), 2019, angiography of left limb revealed occlusion of left sfa and posterior tibial artery.Additional event core lab angiography revealed patent inflow and outflow.However, occlusive isr pattern was noted with presence of thrombus and absence of aneurysm.On the same day, 100% stenosis with 370 mm long in the target lesion with 5 mm reference vessel diameter of 5 mm was thrombolysed rotationally using 6f-rotarex system repeatedly.Post thrombectomy, stent was extended proximally with 6 mm x 100mm ivolution stent.Post-dilation was performed using 5 mm x 120 mm pacific balloon and dilatation of popliteal artery was continued from pii up to pi segment with the same balloon.Due to in-stent residual stenosis, pronounced dissection was noted.Hence, extension of the stent implantation up to p2 with 5.5 mm x 80 mm supera stent was performed.Post treatment, residual stenosis was 10%.Pre-discharge abi on the left was 1.06.On (b)(6) 2019, the event was considered recovered/resolved and the patient was discharged on aspirin and plavix in a good general condition.It was further reported that on (b)(6) 2019, the patient had symptoms of weightbearing pain in the left calf.

• 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
• MDR Report Key: 8768843
• MDR Text Key: 150308819
• Report Number: 2134265-2019-07098
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2020

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 Expiration Date: 10/09/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022905278
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 03/26/2020; 04/02/2020
• Supplement Dates FDA Received: 04/01/2020; 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR