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

Model Number	24657
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent partially deployed then fractured, resulting in embolization, and requiring intervention.This 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for use during a superficial femoral artery (sfa) stenting procedure.The 99% chronically occluded sfa was moderately calcified and moderately tortuous.The lesion was predilated using a 4mm balloon, then an attempt was made to implant this stent.During deployment using the thumb wheel, approximately 1cm of the stent deployed; however, the remainder of the stent did not deploy despite fully rolling the thumb wheel back.The blue handle was then attempted, but it disconnected from the device.The stent was able to be backed out over the wire, but when trying to pull it back in the sheath, the exposed portion of stent fractured distally 10mm and embolized to the femoral artery.The piece was able to be snared, and the procedure was completed with a different stent.The procedure was prolonged, but the patient fully recovered.
Event or Problem Description
It was reported that the stent partially deployed then fractured, resulting in embolization, and requiring intervention.This 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for use during a superficial femoral artery (sfa) stenting procedure.The 99% chronically occluded sfa was moderately calcified and moderately tortuous.During the procedure, the chronic total occlusion in the sfa/popliteal was crossed and the lesion was predilated using a 4mm balloon, then they advanced the device to below knee popliteal.An attempt was made to implant this stent; however, during deployment using the thumb wheel, approximately 1cm of the stent deployed.The remainder of the stent did not deploy despite fully rolling the thumb wheel back.The blue handle was then attempted, but it disconnected from the device.The stent was able to be backed out over the wire, but when trying to pull it back in the sheath, the exposed portion of stent fractured distally 10mm and embolized to the femoral artery.The piece was able to be snared, and the procedure was completed with a different stent.The procedure was prolonged, but the patient fully recovered.It was further reported that the device was being deployed in the popliteal 2 segment below the knee.The previous report of embolization was further clarified as the detached/fractured stent piece traveled to the femoral artery and the physician successfully snared out the entire end piece.
Additional Manufacturer Narrative
Corrected b5: describe event or problem device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia self-expanding stent system was returned fractured into two pieces; likely caused during the interaction of the sheath when attempting to remove from the body.The exposed stent measured 3.5cm and the recovered piece measured 10mm.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual and microscopic examination revealed bunching at the nose cone and a broken rack/pull grip.Inspection of the remainder of the device revealed no other damage or irregularities.The reported clinical observations of partial deploy, fracture, and difficult to remove were confirmed.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20413081
• Report Number: 2124215-2024-61971
• Device Sequence Number: 18237725
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2025
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0032563405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown