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 Reocclusion (1985)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that reocclusion of the implanted stent occurred.The patient was enrolled in the eminent clinical study.On (b)(6) 2017, the index procedure was performed.The target lesion was located in the right mid superficial femoral artery (sfa).The target lesion has a reference vessel diameter of 4mm proximally and distally.The lesion had a total length of 70mm and was 100% occluded.Pre-dilatation was performed using one balloon.After pre-dilatation, a 6mm x 100mm stent was placed.Post-dilatation was performed using one balloon.There was 0% stenosis following the procedure, and no thrombus was seen in the treated vessel.On (b)(6) 2018, the patient was diagnosed with reocclusion of the right sfa.The patient is currently awaiting future appointments to determine if intervention will be performed.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8125735
• MDR Text Key: 129081781
• Report Number: 2134265-2018-63229
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/03/2018

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: 01/31/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019631130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2016
• 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 Age: 64 YR