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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: over 18.Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system from batch 24285492-105.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual and microscopic examination revealed no damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis could not confirm any issues with the label since no packaging was returned for analysis.
Event or Problem Description
It was reported that the labeling was incorrect.The 100mm target lesion was located in the proximal superficial femoral artery (sfa).A 6mm x 100mm x 130cm eluvia self expanding stent was selected to be implanted.The stent delivery system was advanced to the patient.Prior to deployment it was observed by the physician that the stent appeared very short on fluoroscopy.The box and internal packaging confirmed the size to be 6mm x 100mm x 130cm.The physician checked the stent delivery handle and it was labeled 6mm x 40mm x 130cm.The stent delivery system was removed from the patient.A new 6mm x 100mm x 130cm stent was selected and deployed without any issue.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; two scimed place; maple grove MN 55311
• MDR Report Key: 11655471
• Report Number: 2134265-2021-04491
• Device Sequence Number: 3610057
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: 07/31/2021
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0025838357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1