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

Model Number 24653

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Event Description

It was reported that entrapment on guidewire occurred.The 100% stenosed target lesion was located in the severely calcified superficial femoral artery (sfa).A 6x120x130cm eluvia drug-eluting vascular stent system was selected for use.Contralateral approach was performed.The tortuosity was severe in the external iliac artery (eia) on the puncture side.On the opposite side, a non-bsc 0.014 system embolic device was used and advanced along its guidewire.The stent was placed.After stent placement, the delivery system became caught with the non-bsc embolic system and was difficult to remove from the patient.The delivery system of the stent was removed with the non-bsc embolic system as one.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of an eluvia self-expanding stent system with a 0.014 inch wire in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a twist to the outer sheath at the nosecone.The handle is missing.Microscopic examination revealed no additional damages.The returned 0.014 inch guidewire was removed from the device.Functional testing as performed by inserting a test 0.035 inch guidewire into the device and there was resistance at the nosecone.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that entrapment on guidewire occurred.The 100% stenosed target lesion was located in the severely calcified superficial femoral artery (sfa).A 6x120x130cm eluvia drug-eluting vascular stent system was selected for use.Contralateral approach was performed.The tortuosity was severe in the external iliac artery (eia) on the puncture side.On the opposite side, a non-bsc 0.014 system embolic device was used and advanced along its guidewire.The stent was placed.After stent placement, the delivery system became caught with the non-bsc embolic system and was difficult to remove from the patient.The delivery system of the stent was removed with the non-bsc embolic system as one.There were no patient complications.

• 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: 10283174
• MDR Text Key: 199086031
• Report Number: 2134265-2020-09379
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023829503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: PARACHUTE; GUIDEWIRE: PARACHUTE; INTRODUCER SHEATH: PARENT; INTRODUCER SHEATH: PARENT; GUIDEWIRE: PARACHUTE; INTRODUCER SHEATH: PARENT