MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reocclusion (1985)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

Age at the time of event: (b)(6) years old at the time of enrollment.Device is a combination product.

Event Description

It was reported that restenosis occurred.On (b)(6) 2016, the patent was enrolled in the imperial study and the index procedure was performed the same day.The target lesion was located in the right leg mid superficial femoral artery (sfa) with 100% stenosis and was 125mm long with a proximal reference vessel diameter of 4mm and distal vessel diameter of 4mm and was classified as tasc ii d lesion.The lesion was treated with pre-dilatation and placement of a 6.0 x 150mm study stent.Following post dilatation, residual stenosis was 0%.On (b)(6) 2018, during the 24 month follow up, dus was performed and revealed 50-99% in-stent restenosis of the previously placed study stent in the proximal portion of the right sfa - neointimal hyperplasia.On (b)(6) 2018, the patient was hospitalized for further evaluation and treatment.On the same day, 80% in-stent restenosis of the previously placed study stent in the proximal portion of the right sfa was treated with laser athrectomy and placement of a 6 x 40mm zilver stent.Post dilatation, there was no evidence of embolization or dissection.The patient was discharged on the same day on dapt.

• Brand Name: ELUVIATM 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: 8168912
• MDR Text Key: 130479456
• Report Number: 2134265-2018-64286
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 18822230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention