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	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently deployed.This 7x40, 130 cm eluvia drug-eluting vascular stent system was selected for use in a procedure for peripheral artery disease.Upon opening the device packaging, the stent was partially deployed.It appeared that the thumbwheel protector and rear blue pull tab were intact, and the distal portion of the stent was exposed and partially flared out.The procedure was completed using a new stent.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 that the stent was partially deployed 7mm from the distal end of the middle sheath.The outer sheath was kinked at the nosecone.Microscopic examination revealed no additional damages.The pull rack and thumbwheel lock were still in the manufactured position.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that could have contributed to the inadvertent deployment.
Event or Problem Description
It was reported that the stent inadvertently deployed.This 7x40, 130 cm eluvia drug-eluting vascular stent system was selected for use in a procedure for peripheral artery disease.Upon opening the device packaging, the stent was partially deployed.It appeared that the thumbwheel protector and rear blue pull tab were intact, and the distal portion of the stent was exposed and partially flared out.The procedure was completed using a new stent.There were no patient complications.

• 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: 17442213
• Report Number: 2124215-2023-40982
• Device Sequence Number: 2735893
• Product Code: NIU
• UDI-Device Identifier: 08714729876694
• UDI-Public: 08714729876694
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 10/10/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030579263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown