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	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system from batch 24285492.The shelf box and device pouch also returned for analysis.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kinked to the outer sheath at the nosecone.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.The target lesion was approximately 100mm long.During preparation, upon removal from packaging, the device was found to be the incorrect size.The package was labeled 6mm x 100mm, but the stent inside was 6mm x 40mm.The stent appeared shorter than the expected 100mm length, and the handle of the device had 6 x 40 printed on it.It was noted that the inner pouch matched the outer carton/shelf carton.The stent was not implanted.The procedure was completed with another 6mm x 100mm eluvia without issue.No patient complications were reported.

• 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: 11565996
• Report Number: 2134265-2021-03833
• Device Sequence Number: 11973328
• Product Code: NIU
• UDI-Device Identifier: 08714729876601
• UDI-Public: 08714729876601
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 03/24/2021

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: 03/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/24/2021
• Patient Sequence Number: 1