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 Occlusion (1984); Thrombosis (2100)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Device is a combination product.

Event Description

(b)(6).It was reported that in-stent occlusion occurred.The subject was enrolled in the (b)(6) on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in right mid superficial femoral artery (sfa) and was 91% stenosed.The lesion was 85 mm long with a proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 5 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilation, followed by placement of a 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet medications.On (b)(6) 2019, the subject was noted to have an occluded sfa stent.The subject was hospitalized on the same day for treatment, and right femoral popliteal bypass was done as treatment.On (b)(6) 2019, the event was recovered/resolved and the subject was discharged on the same day.

Event Description

Eminent clinical study.It was reported that in-stent occlusion occurred.The subject was enrolled in the eminent clinical study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in right mid superficial femoral artery (sfa) and was 91% stenosed.The lesion was 85 mm long with a proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 5 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilation, followed by placement of a 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet medications.On (b)(6) 2019, the subject was noted to have an occluded sfa stent.The subject was hospitalized on the same day for treatment, and right femoral popliteal bypass was done as treatment.On (b)(6) 2019, the event was recovered/resolved and the subject was discharged on the same day.It was further reported that on (b)(6) 2018, there was significant right proximal sfa stenosis just beyond the origin of the sfa.On (b)(6) 2018, the study stent was occluded in the sfa.Additionally, stent thrombosis was reported on (b)(6) 2019.The event was recovered/resolved on (b)(6) 2019 and the subject was discharged on the same day.

Manufacturer Narrative

A1: patient identifier: (b)(6).

• 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: 10155119
• MDR Text Key: 195166705
• Report Number: 2134265-2020-07955
• 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: 09/21/2020

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: 12/05/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020906846
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 54 YR