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

Model Number 24657

Device Problem Fracture (1260)

Patient Problems Thrombosis (2100); No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that the stent fractured.A 6x120m eluvia stent was placed on (b)(6) 2018 in the superficial femoral artery (sfa).The index procedure was reported to be fine and there were no reported difficulties during deployment.The patient returned on (b)(6) 2018 for another procedure.Upon imaging, the eluvia stent appeared to be fractured in the middle of the stent and there was no blood flow through the stent.The physician performed an angiojet procedure to reopen the stent and restore blood flow.There were no patient complications reported.

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that the stent fractured.A 6x120m eluvia stent was placed on (b)(6) 2018 in the superficial femoral artery (sfa).The index procedure was reported to be fine and there were no reported difficulties during deployment.The patient returned on (b)(6) 2018 for another procedure.Upon imaging, the eluvia stent appeared to be fractured in the middle of the stent and there was no blood flow through the stent.The physician performed an angiojet procedure to reopen the stent and restore blood flow.There were no patient complications reported.It was further reported that after the stent fracture, thrombus was observed in the stent.The physician believes the stent fracture caused the thrombus to occur.There was no blood flow through the stent due to the thrombus.Angiojet was used to treat the thrombus and restore blood flow.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8173670
• MDR Text Key: 130643338
• Report Number: 2134265-2018-64426
• 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,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2019
• 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): Other; Required Intervention