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 08/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Age at time of event: subject was (b)(6) at time of enrollment.

Event Description

It was reported that an occlusion occurred.The subject was enrolled in the eminent study on 09 may 2018 and the index procedure was performed on the same day.The target lesion was located in right proximal to distal superficial femoral artery (sfa) with 80% stenosis and was 95 mm long with a proximal reference vessel diameter of 5.9 mm and distal reference vessel diameter of 5.8 mm and was classified as tasc ii b lesion.The target lesion was predilated followed by placement of a 6 mm x 100 mm study stent was implanted.Post dilatation was not performed.Residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2020, diagnosis revealed occlusion in the stent.The event was considered to be non-serious and medication was given as treatment.No additional patient complications have been reported.

• 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: 10541484
• MDR Text Key: 207193063
• Report Number: 2134265-2020-12802
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020648712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2017
• 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