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 Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent deployment occurred.A 6m x 150mm, 130 cm eluvia drug-eluting vascular stent system was selected for use.However, during preparation, it was observed that the stent was partially deployed while still in the package.The product was not used.The procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Duplicate reports were submitted for this event.Any additional information pertaining to the event will be submitted under emdr 2124215-2024-53102.Device eval by manufacturer: returned product consisted of an eluvia drug-eluting vascular stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed multiple kinks to the sheath.The stent was partially deployed 3mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack were still in the manufactured position.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the inadvertent deployment.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 6m x 150mm, 130 cm eluvia drug-eluting vascular stent system was selected for use.However, during preparation, it was observed that the stent was partially deployed while still in the package.The product was not used.The procedure was completed using an alternate device.No 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20064298
• Report Number: 2124215-2024-53102
• Device Sequence Number: 15660048
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 10/04/2024

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: 05/25/2025
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0031852483
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown