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	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system from batch 24285492.The shelf box and device pouch were also returned for analysis.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual and microscopic examination revealed no damages.The device pouch label was held over a light and the batch number underneath was visible.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis confirmed the label underneath has the batch number matching the returned device.
Event or Problem Description
It was reported that the stent inside the packaging was the incorrect size.An eluvia drug-eluting vascular stent system was selected for use in a procedure within the superficial femoral artery (sfa).The target lesion was 100mm long.During preparation, the packaging was opened, and the device inside was the incorrect size.The package was labeled 6mm x 100mm, but the stent size was determined to be 6mm x 40mm by balloon comparison.It was noted that the inner pouch matched the outer carton/shelf carton.The 6mm x 40mm stent was implanted anyway to avoid waste.No patient complications were reported.
Event or Problem Description
It was reported that the stent inside the packaging was the incorrect size.An eluvia drug-eluting vascular stent system was selected for use in a procedure within the superficial femoral artery (sfa).The target lesion was 100mm long.During preparation, the packaging was opened, and the device inside was the incorrect size.The package was labeled 6mm x 100mm, but the stent size was determined to be 6mm x 40mm by balloon comparison.It was noted that the inner pouch matched the outer carton/shelf carton.The 6mm x 40mm stent was implanted anyway to avoid waste.No patient complications were reported.It was further reported that a drug-coated balloon was used to treat the additional lesion length.
Additional Manufacturer Narrative
A2: age at time of event - 18 years or older.Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system from batch 24285492.The shelf box and device pouch were also returned for analysis.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual and microscopic examination revealed no damages.The device pouch label was held over a light and the batch number underneath was visible.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis confirmed the label underneath has the batch number matching the returned device.

• 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: 11465824
• Report Number: 2134265-2021-02979
• Device Sequence Number: 19820248
• Product Code: NIU
• UDI-Device Identifier: 08714729876571
• UDI-Public: 08714729876571
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/03/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention