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 Reocclusion (1985); Thrombosis (2100)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) study it was reported that in-stent restenosis and stent thrombosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in the right mid to distal superficial femoral artery (sfa) involving the proximal popliteal artery.The stenosis was 100% and the target lesion was 100 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was pre-dilated, and two study stents 6 mm x 120mm and 6mm x 40mm were implanted to treat the lesion.Following post dilation, residual stenosis was 5%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, 753 days post index procedure, the subject developed stenosis in the right sfa.On the same day, the subject was hospitalized for further evaluation and treatment.Angiography was performed as a diagnostic measure and which revealed presence of stenosis and thrombus in the target lesion.On (b)(6) 2020, 753 days post index procedure, 100% stenosis with 400 mm lesion length and reference vessel diameter of 6 mm was treated with percutaneous transluminal angioplasty, placement of a stent, atherectomy and drug coated balloon dilation was also performed.Post treatment revealed residual stenosis of 25%.On (b)(6) 2020, the event was considered to be recovered/resolved.On (b)(6) 2020, the subject was discharged.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10115379
• MDR Text Key: 193701626
• Report Number: 2134265-2020-07406
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019873609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR