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	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was partially deployed and stretched.A 6mm x 150mm, 130cm eluvia drug-eluting vascular stent system was selected for use.A contralateral approach was used to access the target lesion that was highly calcified and located in moderately tortuous anatomy.The vessel was prepped with balloon angioplasty.During the procedure, after deploying 2cm of the stent, the rest of the stent would not un-sheath despite using the thumbwheel to its maximum capability.The force required to turn the thumbwheel was high.The pull grip was used, but additional manipulation to the deployment system was required in order to deploy the stent.The deployment handle was broken open in order to deploy the stent manually.The stent was ultimately implanted but elongated 4cm.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system with a 0.014" guidewire in the device.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed that the handle was open.There were multiple kinks along the sheath.The proximal inner liner was prolapsed.Microscopic examination revealed no additional damages.The thumbwheel was not returned for analysis.Product analysis confirmed that the sheath was kinked which would have contributed to the deployment issue and stent deformation.
Event or Problem Description
It was reported that the stent was partially deployed and stretched.A 6mm x 150mm, 130cm eluvia drug-eluting vascular stent system was selected for use.A contralateral approach was used to access the target lesion that was highly calcified and located in moderately tortuous anatomy.The vessel was prepped with balloon angioplasty.During the procedure, after deploying 2cm of the stent, the rest of the stent would not un-sheath despite using the thumbwheel to its maximum capability.The force required to turn the thumbwheel was high.The pull grip was used, but additional manipulation to the deployment system was required in order to deploy the stent.The deployment handle was broken open in order to deploy the stent manually.The stent was ultimately implanted but elongated 4cm.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; 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: 20015515
• Report Number: 2124215-2024-51090
• Device Sequence Number: 8601276
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/20/2024

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: 02/15/2026
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0033610070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown