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	Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently deployed.This 7x60, 130 cm eluvia drug-eluting vascular stent system was selected for use in a runoff procedure for peripheral artery disease.The stent system was loaded over a non-boston scientific guidewire.As soon as the stent was loaded on the wire, it was difficult to advance; therefore, the stent system was removed from the wire.However, when pulling it off the wire the stent inadvertently deployed.It was noted that the stent never entered the patients body.The procedure was completed with a new stent and there were no patient complications.
Event or Problem Description
It was reported that the stent inadvertently deployed.This 7x60, 130 cm eluvia drug-eluting vascular stent system was selected for use in a runoff procedure for peripheral artery disease.The stent system was loaded over a non-boston scientific guidewire.As soon as the stent was loaded on the wire, it was difficult to advance; therefore, the stent system was removed from the wire.However, when pulling it off the wire the stent inadvertently deployed.It was noted that the stent never entered the patients body.The procedure was completed with a new stent and there were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia drug-eluting vascular stent system was inspected for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent was partially deployed 15mm 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 confirmed that the stent was partially deployed.

• 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: 17745131
• Report Number: 2124215-2023-50277
• Device Sequence Number: 5654270
• Product Code: NIU
• UDI-Device Identifier: 08714729876700
• UDI-Public: 08714729876700
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 10/25/2023

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: 04/06/2025
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0031634909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLIDE ADVANTAGE WIRE; GLIDE ADVANTAGE WIRE
• Patient Sex: Unknown