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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that a stent fracture occurred.The patient was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed the same day.The lesion was located in the mid superficial femoral artery (sfa) extending to the distal sfa with 99% stenosis and was 130 mm long with a proximal reference vessel diameter of 5.00 mm and distal vessel diameter of 5.00 and was classified as tasc ii c lesion.The lesion was treated with pre-dilatation and placement of a 6mm x150mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, the patient was discharged with anti-platelet medication.On (b)(6) 2018, the patient was noted to have a stent fracture in the left sfa of the stent that was implanted during the index procedure.An x-ray of the target limb was performed.

• 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: 8071515
• MDR Text Key: 127206001
• Report Number: 2134265-2018-62892
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• 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: 18822232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• 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 Age: 74 YR