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 Pain (1994); Thrombosis (2100)

Event Date 12/15/2020

Event Type  Injury  

Event Description

It was reported that thrombosis occurred.Two 6mm x 60mm x 130cm eluvia drug-eluting vascular stent systems were selected for use in a stent procedure in the femoral artery to treat a dissection.Both stents were implanted on (b)(6) 2020 over the dissection.The patient was okay post-procedure.On (b)(6) 2020, the patient was experiencing pain in the calf.Medical imaging showed the patient had thrombosis in the femoral artery.The clot, which was partially in the eluvia stents, was removed through aspiration using a non-boston scientific device.Another eluvia stent was implanted and angioplasty was performed in the femoral artery.The patient was not able to be on anticoagulants post-procedure due to their medical history.The patient was expected to fully recover.

• 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: 11072455
• MDR Text Key: 223618994
• Report Number: 2134265-2020-18206
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0024663670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2019
• 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
• Treatment: WALK VASCULAR JETI
• Patient Outcome(s): Required Intervention