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 Problem Thrombosis (2100)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Initial reporter facility name: (b)(6).Device is a combination device.

Event Description

(b)(6) study.It was reported that thrombosis occurred.The patient underwent treatment with the eluvia trial device on (b)(6) 2018 as part of the (b)(6) clinical trial.The target lesion was in the left mid and distal superficial femoral artery (sfa) (proximal popliteal artery not involved) with 6mm proximal and distal reference diameter, 280mm of length and 100% stenosed.Pre-dilatation was performed using one balloon and the lesion was crossed subintimal.Two stents were implanted (6x120mm and 6x120mm).An additional non-bsc stent was implanted (6x40mm, because of residual stenosis.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, the patient experienced a target vessel occlusion.Stent thrombosis occurred in the eluvia stent (mid and distal sfa) and on the additional stent (distal sfa).The event is assessed as ongoing.

Manufacturer Narrative

Describe event or problem: additional information: patient identifier: (b)(6).Date of birth: 1949.Initial reporter phone: (b)(6).Initial reporter facility name: (b)(6).Device is a combination device.

Event Description

Regal clinical study.It was reported that thrombosis occurred.The patient underwent treatment with the eluvia trial device on (b)(6).2018 as part of the regal clinical trial.The target lesion was in the left mid and distal superficial femoral artery (sfa) (proximal popliteal artery not involved) with 6mm proximal and distal reference diameter, 280mm of length and 100% stenosed.Pre-dilatation was performed using one balloon and the lesion was crossed subintimal.Two stents were implanted (6x120mm and 6x120mm).An additional non-bsc stent was implanted (6x40mm, because of residual stenosis.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, the patient experienced a target vessel occlusion.Stent thrombosis occurred in the eluvia stent (mid and distal sfa) and on the additional stent (distal sfa).The event is assessed as ongoing.It was further reported, on (b)(4).2019, the patient was hospitalized to undergo intervention due to target vessel occlusion and stent thrombosis in the eluvia stent (mid and distal sfa) and on the additional stent (distal sfa).Pta and stenting were performed (target lesion revascularization).The event is assessed as resolved as of (b)(6).2019.

• 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: 8566229
• MDR Text Key: 143598039
• Report Number: 2134265-2019-04520
• 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
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021388754
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 05/31/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR