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

Model Number 24653

Device Problem Fracture (1260)

Patient Problem Claudication (2550)

Event Date 01/13/2020

Event Type  Injury  

Event Description

It was reported that the stent fractured and the patient experienced recurrent claudication.A 6x120 130cm eluvia drug-eluting vascular stent system was implanted in the superficial femoral artery (sfa) during a procedure on (b)(6) 2017.The patient returned to the lab with recurrent claudication in (b)(6) 2020.Upon angiographic follow-up, the eluvia stent was noted to be fractured in multiple locations and appeared to almost be disintegrated.Revascularization was performed and endovascular repair of the stent was completed successfully.The patient's status post procedure was excellent and no further claudication was noted.

Event Description

It was reported that the stent fractured and the patient experienced recurrent claudication.A 6x120 130cm eluvia drug-eluting vascular stent system was implanted in the superficial femoral artery (sfa) during a procedure on (b)(6)2017.The patient returned to the lab with recurrent claudication in (b)(6)2020.Upon angiographic follow-up, the eluvia stent was noted to be fractured in multiple locations and appeared to almost be disintegrated.Revascularization was performed and endovascular repair of the stent was completed successfully.The patient's status post procedure was excellent and no further claudication was noted.

Manufacturer Narrative

Device eval by manufacturer: the device was not returned for analysis.Media was provided by the customer.There were five photos provided numbered 1, 4, 6, 14, and 15.Photo 1 shows the patient's two legs.The right leg in the photo has an area with a break in the flow.Photo 4 shows the stent that is in the vessel.Photo 6 shows the stent fractured in three locations.Photo 14 shows a guidewire threaded through the vessel with a new stent implanted inside of the fractured stent.Photo 15 shows the proximal end of the implanted second stent.

• 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
• MDR Report Key: 9733180
• MDR Text Key: 180412986
• Report Number: 2134265-2020-01783
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019873608
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention