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	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this eluvia self-expanding stent system was returned with a 0.014-inch guidewire in the device.The outer sheath, tip, inner sheath, and the remainder of the device were inspected for damage.Visual examination revealed that the handle was open.There were multiple kinks along the middle sheath.There were multiple bucklings along the outer sheath.The proximal inner liner was prolapsed.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the clinical observations.
Event or Problem Description
It was reported that the device partially deployed, stretched, and was deployed across a non-target vessel, requiring an additional device.This 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in a left leg angiogram and atherectomy procedure.Using a contralateral approach, the target lesion was located in the 70% stenosed, mildly calcified left superficial femoral artery.While attempting to place this stent, it was noted that the deployment wheel felt stiff, and elevated force was required to turn the wheel.It then began to spin freely while 100mm of the stent was still constrained.The handle was already fully extended; therefore, the deployment mechanism was opened to manually deploy the stent.However, the inner mechanism was kinked.While attempting to retract the device, the stent became elongated an additional 100 to 150mm, and was deployed across a non-target vessel.The deployed stent was post dilated and additional stents were implanted inside the stent.The procedure was completed, and the patient fully recovered.
Event or Problem Description
It was reported that the device partially deployed, stretched, and was deployed across a non-target vessel, requiring an additional device.This 7x150, 130 cm eluvia drug-eluting vascular stent system was selected for use in a left leg angiogram and atherectomy procedure.Using a contralateral approach, the target lesion was located in the 70% stenosed, mildly calcified left superficial femoral artery.While attempting to place this stent, it was noted that the deployment wheel felt stiff, and elevated force was required to turn the wheel.It then began to spin freely while 100mm of the stent was still constrained.The handle was already fully extended; therefore, the deployment mechanism was opened to manually deploy the stent.However, the inner mechanism was kinked.While attempting to retract the device, the stent became elongated an additional 100 to 150mm, and was deployed across a non-target vessel.The deployed stent was post dilated and additional stents were implanted inside the stent.The procedure was completed, and the patient fully recovered.

• 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: 19311131
• Report Number: 2124215-2024-29255
• Device Sequence Number: 3063310
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: 08714729876748
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 06/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030842407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELUVIA, VIABAHNS,SPARTACORE, STERLING; ELUVIA, VIABAHNS,SPARTACORE, STERLING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown