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

Model Number 24620

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Reocclusion (1985); Thrombosis (2100); Claudication (2550)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(6).

Event Description

(b)(6) clinical study.It was reported that thrombosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The 90% stenosed and 135mm long target lesion was located mid-superficial femoral artery (sfa) and extended to the left distal sfa.The lesion had a proximal reference vessel diameter of 6 mm and distal vessel diameter of 5.5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of a 6mmx150 mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2019, the subject was noted with re-occlusion in the left sfa and popliteal artery.On (b)(6) 2020, the subject was hospitalized for further evaluation and treatment.On (b)(6) 2020, 1263 days post procedure, 100% reocclusion noted in the left sfa and popliteal artery was treated by performing percutaneous interventions (percutaneous transluminal angioplasty, drug coated balloon, thrombectomy and aspiration embolectomy), with a placement of 2 stents with 0% residual stenosis.On (b)(6) 2020, the event was considered resolved and the subject was discharged on the same day.

Manufacturer Narrative

Device is a combination product.E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).

Event Description

Imperial clinical study: it was reported that thrombosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The 90% stenosed and 135mm long target lesion was located mid-superficial femoral artery (sfa) and extended to the left distal sfa.The lesion had a proximal reference vessel diameter of 6 mm and distal vessel diameter of 5.5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of a 6mmx150 mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2019, the subject was noted with re-occlusion in the left sfa and popliteal artery.On (b)(6) 2020, the subject was hospitalized for further evaluation and treatment.On (b)(6) 2020, 1263 days post procedure, 100% reocclusion noted in the left sfa and popliteal artery was treated by performing percutaneous interventions (percutaneous transluminal angioplasty (pta), drug coated balloon, thrombectomy and aspiration embolectomy), with a placement of 2 stents with 0% residual stenosis.On (b)(6) 2020, the event was considered resolved and the subject was discharged on the same day.It was further reported that: on (b)(6) 2020, the subject presented to the hospital with the complaint of claudication in the left leg usually induced after a short stretch of walking and subsequently was hospitalized for further evaluation and treatment.On (b)(6) 2020, 1263 days post procedure, successful recanalization of superficial femoral artery and popliteal artery along with thrombus aspiration from the distal fibular artery and side branch coiling proximal fibular artery medially to the left was done by pta.On (b)(6) 2020, color duplex ultrasound of the arteries in the lower leg was performed which revealed femoropopliteal artery with strong perfusion, mild residual stenosis on the p1 segment, strong flow in the popliteal artery, perfused fibular artery until the distal segment.No evidence of complication was noted at the puncture site.On (b)(6) 2020, the event was considered to be resolved and on the same day the subject was discharged on aspirin and clopidogrel.

Event Description

Imperial clinical study.It was reported that thrombosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The 90% stenosed and 135mm long target lesion was located mid-superficial femoral artery (sfa) and extended to the left distal sfa.The lesion had a proximal reference vessel diameter of 6 mm and distal vessel diameter of 5.5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of a 6mmx150 mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2019, the subject was noted with re-occlusion in the left sfa and popliteal artery.On (b)(6) 2020, the subject was hospitalized for further evaluation and treatment.On (b)(6) 2020, 1263 days post procedure, 100% reocclusion noted in the left sfa and popliteal artery was treated by performing percutaneous interventions (percutaneous transluminal angioplasty (pta), drug coated balloon, thrombectomy and aspiration embolectomy), with a placement of 2 stents with 0% residual stenosis.On (b)(6) 2020, the event was considered resolved and the subject was discharged on the same day.It was further reported that: on (b)(6) 2020, the subject presented to the hospital with the complaint of claudication in the left leg usually induced after a short stretch of walking and subsequently was hospitalized for further evaluation and treatment.On (b)(6) 2020, 1263 days post procedure, successful recanalization of superficial femoral artery and popliteal artery along with thrombus aspiration from the distal fibular artery and side branch coiling proximal fibular artery medially to the left was done by pta.On (b)(6) 2020, color duplex ultrasound of the arteries in the lower leg was performed which revealed femoropopliteal artery with strong perfusion, mild residual stenosis on the p1 segment, strong flow in the popliteal artery, perfused fibular artery until the distal segment.No evidence of complication was noted at the puncture site.On (b)(6) 2020, the event was considered to be resolved and on the same day the subject was discharged on aspirin and clopidogrel.It was further reported that: on (b)(6) 2020, angiography was performed which revealed occlusion of the stented segment mid sfa extending to distal sfa and suspicion of non-dislocated stent fractures in mid sfa with severe stenosis in proximal and mid segments of popliteal artery occlusion of the posterior tibial artery and anterior tibial artery.On (b)(6) 2020, 1263 days post procedure, occlusion in the study stent located in left mid sfa extending to distal sfa was initially treated by performing thrombectomy followed by drug coated balloon angioplasty using 6/40 mm non-bsc balloon.Then, a 5.5 mm non-bsc stent was deployed in the middle stent chain and an additional 6 mm non-bsc stent was deployed to treat the residual stenosis noted towards the proximal sfa.Additionally, the stenosis noted in proximal and mid portion of popliteal artery was treated by performing drug coated balloon angioplasty using 6/150 mm non-bsc balloon.Also, aspiration embolectomy was performed to treat stenosis in the tibial artery.

Manufacturer Narrative

Device is a combination product.E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).

Event Description

Imperial clinical study it was reported that thrombosis occurred.The subject was enrolled in the imperial study on 19 july, 2016 and the index procedure was performed on the same day.The 90% stenosed and 135mm long target lesion was located mid-superficial femoral artery (sfa) and extended to the left distal sfa.The lesion had a proximal reference vessel diameter of 6 mm and distal vessel diameter of 5.5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of a 6mmx150 mm study stent.Following post-dilatation, residual stenosis was 0%.On 21-jul-2016, the subject was discharged on aspirin and clopidogrel.On 30 december, 2019, the subject was noted with re-occlusion in the left sfa and popliteal artery.On 02 january, 2020, the subject was hospitalized for further evaluation and treatment.On 03 january, 2020, 1263 days post procedure, 100% reocclusion noted in the left sfa and popliteal artery was treated by performing percutaneous interventions (percutaneous transluminal angioplasty (pta), drug coated balloon, thrombectomy and aspiration embolectomy), with a placement of 2 stents with 0% residual stenosis.On 05 january 2020, the event was considered resolved and the subject was discharged on the same day.It was further reported that: on january 2, 2020, the subject presented to the hospital with the complaint of claudication in the left leg usually induced after a short stretch of walking and subsequently was hospitalized for further evaluation and treatment.On january 3, 2020, 1263 days post procedure, successful recanalization of superficial femoral artery and popliteal artery along with thrombus aspiration from the distal fibular artery and side branch coiling proximal fibular artery medially to the left was done by pta.On january 4, 2020, color duplex ultrasound of the arteries in the lower leg was performed which revealed femoropopliteal artery with strong perfusion, mild residual stenosis on the p1 segment, strong flow in the popliteal artery, perfused fibular artery until the distal segment.No evidence of complication was noted at the puncture site.On january 5, 2020, the event was considered to be resolved and on the same day the subject was discharged on aspirin and clopidogrel.It was further reported that: on january 3, 2020, angiography was performed which revealed occlusion of the stented segment mid sfa extending to distal sfa and suspicion of non-dislocated stent fractures in mid sfa with severe stenosis in proximal and mid segments of popliteal artery occlusion of the posterior tibial artery and anterior tibial artery.On january 3, 2020, 1263 days post procedure, occlusion in the study stent located in left mid sfa extending to distal sfa was initially treated by performing thrombectomy followed by drug coated balloon angioplasty using 6/40 mm non-bsc balloon.Then, a 5.5 mm non-bsc stent was deployed in the middle stent chain and an additional 6 mm non-bsc stent was deployed to treat the residual stenosis noted towards the proximal sfa.Additionally, the stenosis noted in proximal and mid portion of popliteal artery was treated by performing drug coated balloon angioplasty using 6/150 mm non-bsc balloon.Also, aspiration embolectomy was performed to treat stenosis in the tibial artery.It was further reported that: on january 3, 2020, angiography identified that the stent fracture was in the middle region of the stented segment.After performing thrombectomy and drug-coated balloon angioplasty, additional balloon angioplasty was performed of stenosed segments before the stented region with a non-boston scientific 6/60 mm balloon.The aspiration embolectomy performed on january 3, 2020 was in the distal fibular artery and side branch coiling in the proximal fibular artery medially to the left.Follow-up core-lab angiography finding dated january 3, 2020, noted grade 0 thrombus, absence of aneurysm and presence of in-stent restenosis pattern 4.No stent deformation and no stent fracture were noted.

• 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: 9627354
• MDR Text Key: 176288423
• Report Number: 2134265-2020-00364
• 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,Followup
• Report Date: 12/07/2020

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?: Yes
• 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
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 02/03/2020; 03/03/2020; 11/19/2020
• Supplement Dates FDA Received: 02/25/2020; 03/11/2020; 12/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR