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 03/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that in-stent stenosis of mid and distal superficial femoral artery (sfa) occurred requiring additional intervention.The patient was enrolled in the eminent clinical study with the patient identifier of (b)(6).The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the mid and distal sfa of the left leg, had a 5mm reference vessel diameter proximal and distal respectively, and a total length of 80mm visually estimated.The target lesion was 90% occluded and crossed through true lumen.Pre-dilatation was performed using one unspecified balloon.Afterwards an eluvia stent (6x100mm) was implanted.Post-dilatation was performed using one unspecified balloon, and 0% residual stenosis remained.On (b)(6) 2019 a re-occlusion of the target lesion left leg was observed.The patient was hospitalized on (b)(6) 2019, and an interventional procedure was performed (lysis and percutaneous transluminal angioplasty).The patient was discharged on (b)(6) 2019.The event was assessed by the investigator as serious and reported as resolved as of (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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8518691
• MDR Text Key: 142082071
• Report Number: 2134265-2019-03496
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• 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: 0019635397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 86 YR