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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: the patient was (b)(6) years old at the time of study enrollment.

Event Description

(b)(6) study.It was reported that a stent fracture occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2016 and the index procedure was performed on the same day.Target lesion #1 was located in the right leg distal superficial femoral artery (sfa) extending to ppa with 100% stenosis and was 150 mm long with a proximal reference vessel diameter of 5.00 mm and distal vessel diameter of 5.00 mm and was classified as tasc ii b lesion.Target lesion #1 was treated with pre-dilatation and placement of a 6.0 x 150 mm, 130cm eluvia drug-eluting vascular study stent.Following post-dilatation, residual stenosis was 10%.On (b)(6) 2016, the subject was discharged on dual antiplatelet therapy.On (b)(6) 2021, during 60 months follow up visit, diagnostic test of x-ray was performed, which was sent to core lab revealing stent fracture of grade ii - multiple tine fracture was noted.No adverse event associated with stent fracture was reported.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13667268
• MDR Text Key: 286646431
• Report Number: 2134265-2022-02342
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• 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: 0018822229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White