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	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed and was potentially stretched as a result.Additionally, the stent migrated post-deployment.An eluvia drug-eluting vascular stent system was selected for use in the superficial femoral artery (sfa) to treat the patient's peripheral artery disease.The eluvia was advanced to the target lesion over an unknown 0.014 in.Guidewire via a contralateral approach and deployment began.Once the stent was deployed approximately half-way, the thumbwheel became loose, and was just spinning, not allowing the stent to fully deploy.The delivery system handle was dismantled, and deployment was completed using a pin-pull method with the innermost catheter and the middle catheter.This allowed the stent to be deployed with integrity.However, the stent appeared to have migrated proximally and may have covered the origin of the profunda.The stent may have been stretched or elongated as a result of the partial deployment.The procedure was completed, and there were no further consequences reported for the patient.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16679163
• Report Number: 2124215-2023-15744
• Device Sequence Number: 18162598
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (Y/N): Y
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028889918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown