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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft of the device broke.A 6x40x130 drug eluting self-expanding stent was selected for use in a peripheral leg intervention.During the procedure, the inner liner of the stent system detached from the rest of the delivery system.The stent was successfully delivered.The delivery system was successfully removed, however, it was in two pieces.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed the pull shaft had separated, a kink to the outer sheath at the nosecone and a kink on the middle sheath.The outer sheath is kinked 6.7 cm from the retainer.The inner liner is kinked 7.7 cm from the tip.The pull rack is separated 4.2 cm from the distal end of the rack.Microscopic examination revealed no additional damages.The handle was opened, and no additional damages were found.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the shaft of the device broke.A 6x40x130 drug eluting self-expanding stent was selected for use in a peripheral leg intervention.During the procedure, the inner liner of the stent system detached from the rest of the delivery system.The stent was successfully delivered.The delivery system was successfully removed, however, it was in two pieces.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: 12059194
• Report Number: 2134265-2021-08052
• Device Sequence Number: 11629267
• Product Code: NIU
• UDI-Device Identifier: 08714729876571
• UDI-Public: 08714729876571
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 02/07/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0026901167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 08/10/2021
• Patient Sequence Number: 1