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 Problem Occlusion (1984)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(6) clinical study.It was reported that occlusion of the implanted study stent occurred.On (b)(6) 2016, the subject was enrolled in the (b)(6) clinical study and the index procedure was performed the same day.Target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis.It was 125 mm long with a proximal vessel diameter of 4.0 mm and distal vessel diameter of 4.0 mm.It was classified as a tasc ii lesion.The target lesion was treated with pre-dilation and placement of a 6 mm x 150 mm study stent.Following post-dilation residual stenosis was 0%.The subject was discharged with dual antiplatelet therapy.On (b)(6) 2019, a bilateral lower extremity ct scan was performed which revealed that there is an occlusion in the right sfa stent.The occlusion was treated medically.

Event Description

Imperial clinical study.It was reported that occlusion of the implanted study stent occurred.On (b)(6) 2016, the subject was enrolled in the imperial clinical study and the index procedure was performed the same day.Target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis.It was 125 mm long with a proximal vessel diameter of 4.0mm and distal vessel diameter of 4.0 mm.It was classified as a tasc ii lesion.The target lesion was treated with pre-dilation and placement of a 6mm x 150 mm study stent.Following post-dilation residual stenosis was 0%.The subject was discharged with dual antiplatelet therapy.On (b)(6) 2019 a bilateral lower extremity ct scan was performed which revealed that there is an occlusion in the right sfa stent.The occlusion was treated medically.It was further reported that on (b)(6) 2019 that the event was considered resolved.

Manufacturer Narrative

Device is combination product.E1: initial reporter facility name - (b)(6).

Manufacturer Narrative

E1: initial reporter facility name - (b)(6).

Event Description

Imperial clinical study: it was reported that occlusion of the implanted study stent occurred.On november 1, 2016, the subject was enrolled in the imperial clinical study and the index procedure was performed the same day.Target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis.It was 125 mm long with a proximal vessel diameter of 4.0mm and distal vessel diameter of 4.0 mm.It was classified as a tasc ii lesion.The target lesion was treated with pre-dilation and placement of a 6mm x 150 mm study stent.Following post-dilation residual stenosis was 0%.The subject was discharged with dual antiplatelet therapy.On (b)(6) 2019 a bilateral lower extremity ct scan was performed which revealed that there is an occlusion in the right sfa stent.The occlusion was treated medically.It was further reported that on (b)(6) 2019 that the event was considered resolved.It was further reported that on (b)(6) 2020, the 90% stenosed 150 mm long lesion noted in the right sfa was treated with atherectomy, endarterectomy, and dilatation with a drug-coated balloon.Post-dilatation, the residual stenosis was noted to be 0%.Additionally, the event was also treated medically.

Event Description

Imperial clinical study.It was reported that occlusion of the implanted study stent occurred.On (b)(6) 2016, the subject was enrolled in the imperial clinical study and the index procedure was performed the same day.Target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis.It was 125 mm long with a proximal vessel diameter of 4.0mm and distal vessel diameter of 4.0 mm.It was classified as a tasc ii lesion.The target lesion was treated with pre-dilation and placement of a 6mm x 150 mm study stent.Following post-dilation residual stenosis was 0%.The subject was discharged with dual antiplatelet therapy.On (b)(6) 2019 a bilateral lower extremity ct scan was performed which revealed that there is an occlusion in the right sfa stent.The occlusion was treated medically.It was further reported that on (b)(6) 2019 that the event was considered resolved.It was further reported that on (b)(6) 2020, the 90% stenosed 150 mm long lesion noted in the right sfa was treated with atherectomy, endarterectomy, and dilatation with a drug-coated balloon.Post-dilatation, the residual stenosis was noted to be 0%.Additionally, the event was also treated medically.It was further clarified that the target lesion was treated with atherectomy, endarterectomy, and dilatation with a drug-coated balloon on (b)(6) 2019.It was initially reported that this occurred on (b)(6) 2020.

Manufacturer Narrative

E1: initial reporter facility name - (b)(6).

• 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: 9128901
• MDR Text Key: 160356403
• Report Number: 2134265-2019-11664
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• 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: 0018822230
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR