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 Occlusion (1984)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6).

Event Description

It was reported that in-stent occlusion 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 left distal superficial femoral artery (sfa) with 90% stenosis and was 30 mm long with a proximal reference vessel diameter of 5 mm and a distal reference vessel diameter of 5 mm and was classified as tasc ii a lesion.The target lesion was treated with direct placement of a 6 mm x 40 mm study stent.Following post dilation, the residual stenosis was 0%.On (b)(6)2018, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject visited the site for protocol scheduled 24-month follow-up visit.(b)(6) classification assessed on (b)(6) 2020 was 0 (asymptomatic) and the ankle brachial index (abi) ratio was 1.Duplex ultrasound performed on (b)(6) 2020 revealed high grade in-stent occlusion of the left sfa.No action was taken to treat the event.Event was considered not recovered/ not resolved.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10927641
• MDR Text Key: 218938165
• Report Number: 2134265-2020-16699
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022272708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• 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): Other
• Patient Age: 60 YR