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	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner packaging seal was open.The box containing this 7x60, 130cm eluvia drug-eluting vascular stent system was opened and it was found that the inner packaging seal was open.The stent was not used and a new stent was able to be used.There was no patient involved.

• 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: 18616945
• Report Number: 2124215-2024-05330
• Device Sequence Number: 19434662
• Product Code: NIU
• UDI-Device Identifier: 08714729876700
• UDI-Public: 08714729876700
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 01/31/2024

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: 08/11/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030131964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown