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	Positioning Failure (1158); Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned product consisted of an eluvia self-expanding stent system and an.014 guidewire stuck in the sheath.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that there was buckling along the whole sheath and showed a partially deployed stent.Visual examination also showed the handle rack was cracked likely caused by tension from advancing the thumbwheel.The guidewire was attempted to be removed with no success.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis confirmed the stent was partially deployed and the guidewire was stuck, the handle rack was also cracked.
Event or Problem Description
Reportable based on device analysis completed on 09aug2024.It was reported that the stent failed to deploy and became stuck on the guidewire.The target lesion was located in a long segment of a moderately calcified superficial femoral artery.A 6x150, 130 cm eluvia drug-eluting vascular stent system was selected for a peripheral artery stenting procedure.The lesion was crossed with a.014 non-boston scientific (bsc) guidwire, then balloon angioplasty was used to pre-dilate the vessel.The eluvia stent was introduced and advanced across the lesion over the.014 wire.It was then attempted to deploy the stent, but when turning the thumb wheel, the outer catheter failed to retract, thus no stent deployment.When it was attempted to remove the entire device, it was stuck on the guidewire.The stent catheter and wire were removed together.The procedure was successfully completed with an innova stent.However, device analysis revealed partial deployment of the stent.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19977022
• Report Number: 2124215-2024-50317
• Device Sequence Number: 18278684
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

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: 12/15/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030886234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown