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 Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent deployed by itself before entering the patient.An 7mm x 40mm x 130cm eluvia drug-eluding vascular stent was chosen as the treatment for peripheral artery disease of the superficial femoral artery.During the procedure, the stent began to prematurely deploy inside of the sheath.The sheath and eluvia were removed together, and it as noted that the stent was fully deployed within the sheath.A different device was used successfully to complete the procedure without sequela.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia drug-eluting vascular stent system with a terumo introducer sheath.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed kinks along the sheath at the nosecone 2.8cm, and 47.3cm from the nosecone.The inner liner was also kinked 5.5cm from the tip.The rack was separated 3cm from the handle (proximal section of the separated rack did not return for analysis).Microscopic examination revealed no additional damages.The stent appears to have been deployed and did not return for analysis.The returned terumo introducer sheath was x-rayed, and the deployed stent was not inside it.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis revealed damage that could have contributed to the reported deployment issue.
Event or Problem Description
It was reported that the stent deployed by itself before entering the patient.An 7mm x 40mm x 130cm eluvia drug-eluding vascular stent was chosen as the treatment for peripheral artery disease of the superficial femoral artery.During the procedure, the stent began to prematurely deploy inside of the sheath.The sheath and eluvia were removed together, and it as noted that the stent was fully deployed within the sheath.A different device was used successfully to complete the procedure without sequela.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15763895
• Report Number: 2124215-2022-46380
• Device Sequence Number: 12326819
• Product Code: NIU
• UDI-Device Identifier: 08714729876694
• UDI-Public: 08714729876694
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 12/14/2022

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: 04/30/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0027458480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown