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); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent surgical intervention as a result of stent damage.An eluvia drug-eluting vascular stent system was selected for use in a stenting procedure.The target lesion was located in the superficial femoral artery (sfa) and was reported to be 50% stenosed with moderate calcification and standard tortuosity.The target lesion was accessed via a contralateral approach and was predilated.The eluvia system was advanced over a v-18 controlwire guidewire.When the physician attempted to deploy the stent within the sfa, approximately half of the stent was able to deploy.The stent could not be fully deployed using normal deployment mechanisms.The handle was taken apart in order to manually deploy the stent.Once the handle was opened, it was observed that the deployment mechanisms were kinked.Approximately 80% of the deployed stent was elongated and appeared fractured.As a result of the device malfunction, the patient had to undergo a full bypass surgery of the femoral artery to remove the stent.No further patient complications were reported.
Additional Manufacturer Narrative
Device analysis: returned product consisted of an eluvia self-expanding stent system with a 0.014 in guidewire in the device.The outer sheath, tip, inner sheath, and the remainder of the device, were checked for damage.Visual examination revealed that the handle was missing.There were multiple kinks along the outer and middle sheath.The proximal inner liner was prolapsed.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis confirmed that sheath was kinked which would have contributed to the deployment issue and stent deformation/fracture.
Event or Problem Description
It was reported that the patient underwent surgical intervention as a result of stent damage.An eluvia drug-eluting vascular stent system was selected for use in a stenting procedure.The target lesion was located in the superficial femoral artery (sfa) and was reported to be 50% stenosed with moderate calcification and standard tortuosity.The target lesion was accessed via a contralateral approach and was predilated.The eluvia system was advanced over a v-18 controlwire guidewire.When the physician attempted to deploy the stent within the sfa, approximately half of the stent was able to deploy.The stent could not be fully deployed using normal deployment mechanisms.The handle was taken apart in order to manually deploy the stent.Once the handle was opened, it was observed that the deployment mechanisms were kinked.Approximately 80% of the deployed stent was elongated and appeared fractured.As a result of the device malfunction, the patient had to undergo a full bypass surgery of the femoral artery to remove the stent.No further patient complications were reported.

• 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; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20232745
• Report Number: 2124215-2024-57782
• Device Sequence Number: 8089899
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/30/2024

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 Model Number: 24657
• Device Catalogue Number: 24657
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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