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

Model Number 24620

Device Problem Fracture (1260)

Patient Problems Reocclusion (1985); No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the stent fractured.The patient was enrolled in the (b)(6) study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right mid superficial femoral artery (sfa) with 85% stenosis and was 120mm long with a proximal reference vessel diameter of 6.00mm and distal vessel diameter of 6.00mm and was classified as tasc iib lesion.The lesion was treated with pre-dilatation and placement of a 6mm x 150mm study stent with 5% residual stenosis.Following post-dilatation, residual stenosis was 5%.On (b)(6) 2016, the patient was discharged on dual antiplatelet medication.On (b)(6) 2018, during the 2 year follow up, an x-ray was performed which revealed a stent fracture in the study stent deployed in the right mid sfa.The device deficiency did not lead to a serious adverse event.

Event Description

It was reported that the stent fractured.The patient was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right mid superficial femoral artery (sfa) with 85% stenosis and was 120mm long with a proximal reference vessel diameter of 6.00mm and distal vessel diameter of 6.00mm and was classified as tasc iib lesion.The lesion was treated with pre-dilatation and placement of a 6mm x 150mm study stent with 5% residual stenosis.Following post-dilatation, residual stenosis was 5%.On (b)(6) 2016, the patient was discharged on dual antiplatelet medication.On (b)(6) 2018, during the 2 year follow up, an x-ray was performed which revealed a stent fracture in the study stent deployed in the right mid sfa.The device deficiency did not lead to a serious adverse event.Additional information reported that during the 24 month follow up, dus core lab dated november 15, 2018, noted isr category as 50-99%.Additionally, dus core lab noted stent fracture at 6cm instent with flow documented between stent wall and artery.There is no further information available at this time.

Manufacturer Narrative

Age at time of event: 62 years old at time of enrollment.Device is a combination product.Adverse event/product problem updated to: adverse event and product problem.

• 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
• MDR Report Key: 8139671
• MDR Text Key: 129576658
• Report Number: 2134265-2018-63613
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 18822229
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other