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 Thrombosis (2100); Claudication (2550); Arteriosclerosis/ Atherosclerosis (4437); Thrombosis/Thrombus (4440)

Event Date 11/08/2018

Event Type  Injury  

Event Description

(b)(4) clinical study.It was reported that in-stent thrombosis occurred.The patient was enrolled in the (b)(6) clinical study with the patient identifier of (b)(6).On (b)(6) 2018, the index procedure was performed.The target lesion was located in the right mid distal superficial femoral artery (sfa).The target lesion had a reference vessel diameter of 6mm, both distally and proximally, was 148mm long, and was 100% stenosed.A 6mm x 120mm eluvia stent and a 6mm x 80mm eluvia stent were implanted in the sfa.Post-dilatation was performed using two dilatation balloons, and residual stenosis was 15%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2018, the patient was hospitalized.On (b)(6) 2018, a ct scan was performed and in-stent thrombosis was detected in the upper part of both stents.An interventional procedure is scheduled for (b)(6) 2018.

Event Description

Eminent clinical study.It was reported that in-stent thrombosis occurred.The patient was enrolled in the eminent clinical study with the patient identifier of (b)(6).On (b)(6) 2018, the index procedure was performed.The target lesion was located in the right mid distal superficial femoral artery (sfa).The target lesion had a reference vessel diameter of 6mm, both distally and proximally, was 148mm long, and was 100% stenosed.A 6mm x 120mm eluvia stent and a 6mm x 80mm eluvia stent were implanted in the sfa.Post-dilatation was performed using two dilatation balloons, and residual stenosis was 15%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2018, the patient was hospitalized.On (b)(6) 2018, a ct scan was performed and in-stent thrombosis was detected in the upper part of both stents.An interventional procedure is scheduled for (b)(6) 2018.It was further reported that the patient was treated with a right "fempop (fp3)" bypass procedure on (b)(6) 2018.The event is considered to be resolved.

Manufacturer Narrative

Device is a combination product.

Event Description

Eminent clinical study: it was reported that in-stent thrombosis occurred.The patient was enrolled in the eminent clinical study with the patient identifier of (b)(6).On (b)(6) 2018, the index procedure was performed.The target lesion was located in the right mid distal superficial femoral artery (sfa).The target lesion had a reference vessel diameter of 6mm, both distally and proximally, was 148mm long, and was 100% stenosed.A 6mm x 120mm eluvia stent and a 6mm x 80mm eluvia stent were implanted in the sfa.Post-dilatation was performed using two dilatation balloons, and residual stenosis was 15%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2018, the patient was hospitalized.On (b)(6) 2018, a ct scan was performed and in-stent thrombosis was detected in the upper part of both stents.An interventional procedure is scheduled for (b)(6) 2018.It was further reported that the patient was treated with a right "fempop (fp3)" bypass procedure on (b)(6) 2018.The event is considered to be resolved.It was further reported that on (b)(6) 2018 the patient presented with complaints of being bedridden for two weeks post index procedure due to right thigh pain.There was persistent claudication, more in the right leg than left leg and pain persisted after walking for about approximately 50 meters.Duplex examination revealed occlusion of the stent in the right sfa.On (b)(6) 2018, the ct angiography of the pelvic arteries- upper leg arteries scanned in arterial phase of right limb revealed complete occlusion of superficial femoral artery, a few centimeters post-ostial, reinjection distally in the popliteal artery, stent in the middle third to distally with only retrograde opacification in the distal stent section was noted.Ct angiography of the pelvic arteries- upper leg arteries scanned in arterial phase of left limb sfa revealed severe atherosclerotic damage with very fragile caliber in the proximal third, followed by complete occlusion.Collateral reinjection distally with limited retrograde opacification in the distal stent section was noted.Due to the findings of early in-stent thrombosis five weeks post index procedure and in view of the patient's symptoms, femoropopliteal bypass was suggested.On (b)(6) 2018, the patient was hospitalized for the planned treatment.Rutherford classification of claudication was assessed as 3 (severe claudication).On (b)(6) 2018, iliofemoral interposition graft and femoropopliteal bypass (p3) was performed in the right leg to treat this event.The event was considered resolved and the subject was discharged in a good condition on aspirin and clopidogrel.

Event Description

Eminent clinical study.It was reported that in-stent thrombosis occurred.The patient was enrolled in the eminent clinical study with the patient identifier of (b)(6).On (b)(6) 2018, the index procedure was performed.The target lesion was located in the right mid distal superficial femoral artery (sfa).The target lesion had a reference vessel diameter of 6mm, both distally and proximally, was 148mm long, and was 100% stenosed.A 6mm x 120mm eluvia stent and a 6mm x 80mm eluvia stent were implanted in the sfa.Post-dilatation was performed using two dilatation balloons, and residual stenosis was 15%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2018, the patient was hospitalized.On (b)(6) 2018, a ct scan was performed and in-stent thrombosis was detected in the upper part of both stents.An interventional procedure is scheduled for (b)(6) 2018.It was further reported that the patient was treated with a right "fempop (fp3)" bypass procedure on (b)(6) 2018.The event is considered to be resolved.It was further reported that on (b)(6) 2018 the patient presented with complaints of being bedridden for two weeks post index procedure due to right thigh pain.There was persistent claudication, more in the right leg than left leg and pain persisted after walking for about approximately 50 meters.Duplex examination revealed occlusion of the stent in the right sfa.On (b)(6) 2018, the ct angiography of the pelvic arteries- upper leg arteries scanned in arterial phase of right limb revealed complete occlusion of superficial femoral artery, a few centimeters post-ostial, reinjection distally in the popliteal artery, stent in the middle third to distally with only retrograde opacification in the distal stent section was noted.Ct angiography of the pelvic arteries- upper leg arteries scanned in arterial phase of left limb sfa revealed severe atherosclerotic damage with very fragile caliber in the proximal third, followed by complete occlusion.Collateral reinjection distally with limited retrograde opacification in the distal stent section was noted.Due to the findings of early in-stent thrombosis five weeks post index procedure and in view of the patient's symptoms, femoropopliteal bypass was suggested.On (b)(6) 2018, the patient was hospitalized for the planned treatment.Rutherford classification of claudication was assessed as 3 (severe claudication).On (b)(6) 2018, iliofemoral interposition graft and femoropopliteal bypass (p3) was performed in the right leg to treat this event.The event was considered resolved and the subject was discharged in a good condition on aspirin and clopidogrel.It was further reported that on (b)(6) 2018 when the p3 procedure was performed, the lesion was 100% stenosed with a reference vessel diameter of 6mm and 40mm length mid- to distal sfa.Post procedure residual stenosis was 0% with absence of thrombus.

• 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: 8129926
• MDR Text Key: 129224530
• Report Number: 2134265-2018-63458
• 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: 07/01/2021

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: 09/10/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021930433
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 12/04/2018; 04/14/2020; 06/07/2021
• Supplement Dates FDA Received: 12/06/2018; 05/04/2020; 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR