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 07/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that in-stent restenosis occurred.The patient underwent treatment with the eluvia device on (b)(6) 2017 as part of the (b)(6) clinical trial.The target lesion, located in the left distal superficial femoral artery (sfa), had a 5.25 reference vessel diameter proximally and 5.33 distally.The lesion had a total length of 80mm.The target lesion was 80% occluded and crossed through true lumen.Pre-dilatation was performed using two balloons after which the 6x100m eluvia stent was implanted.Post-dilatation was not performed.Residual stenosis was 0%.No thrombus was seen at the end of the procedure.On (b)(6) 2018, a stenosis of the proximal and distal end of the study stent was observed.A revascularization was performed on (b)(6) 2019 using two balloons (5mm and 6mm) and placement of two stents.The event was reported as resolved on (b)(6) 2019.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8936970
• MDR Text Key: 156395136
• Report Number: 2134265-2019-10271
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019319118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2016
• 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: 68 YR