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

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Ischemia (1942)

Event Date 06/29/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced redness in the feet.Two 6x120x130 cm eluvia drug-eluting vascular stents were implanted in the superficial femoral artery (sfa).One non-bsc stent was implanted in the tibial artery.Three days post implantation of the stents, the patient's feet showed redness with signs of ischemia.Embolization was suspected.The patient was in stable condition.

Event Description

It was reported that the patient experienced redness in the feet.Two 6x120x130 cm eluvia drug-eluting vascular stents were implanted in the superficial femoral artery (sfa).One non-bsc stent was implanted in the tibial artery.Three days post implantation of the stents, the patient's feet showed redness with signs of ischemia.Embolization was suspected.The patient was in stable condition.It was further reported that the patient's feet looked normal prior to implanting the stents.The 100% stenosed target lesion was located in mild to moderately calcified superficial femoral artery (sfa).Vascular access was gained via ipsilateral downhill puncture.The lesion was predilated.

• 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: 10242140
• MDR Text Key: 197850894
• Report Number: 2134265-2020-09011
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other