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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number 24657
Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/17/2023
Event Type  Injury  
Event Description
It was reported that the stent partially deployed, was difficult to position, and an additional stent was required.The target lesion was heavily calcified and moderately tortuous and located in the superficial femoral artery.The target lesion was chronic total occlusion (cto) and stenosis was 75%.A 6mmx150mm balloon was used to pre-dilate the lesion.A 7x150x130cm eluvia drug-eluting stent was selected for use.Upon deploying the stent, the stent was unable to be completely deployed.The stent deployed normally until the arrow market on the pull grip was displayed.As the physician attempted to deploy the rest of the stent by the pull grip, the stent did not detach from the stent delivery system.Ultimately, forcible pulling on the pull grip, and maneuvering and agitating the stent delivery system allowed the remaining stent to be deployed.However, the stent was not placed in the desired position.The stent stretched causing the stent to migrate from the initial landing zone of the vessel.Another eluvia stent was deployed to overlap with the mispositioned eluvia stent.The procedure was completed.There were no patient complications.
 
Event Description
It was reported that the stent partially deployed, was difficult to position, and an additional stent was required.The target lesion was heavily calcified and moderately tortuous and located in the superficial femoral artery.The target lesion was chronic total occlusion (cto) and stenosis was 75%.A 6mmx150mm balloon was used to pre-dilate the lesion.A 7x150x130cm eluvia drug-eluting stent was selected for use.Upon deploying the stent, the stent was unable to be completely deployed.The stent deployed normally until the arrow market on the pull grip was displayed.As the physician attempted to deploy the rest of the stent by the pull grip, the stent did not detach from the stent delivery system.Ultimately, forcible pulling on the pull grip, and maneuvering and agitating the stent delivery system allowed the remaining stent to be deployed.However, the stent was not placed in the desired position.The stent stretched causing the stent to migrate from the initial landing zone of the vessel.Another eluvia stent was deployed to overlap with the mispositioned eluvia stent.The procedure was completed.There were no patient complications.
 
Manufacturer Narrative
Device analysis by mfr: the device was received and analysis completed.Returned product consisted of an eluvia self-expanding stent system with an unknown 0.014 guidewire stuck 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 is open.There are multiple buckling to the outer sheath.There are multiple kinks along the middle sheath.The proximal inner is prolapsed.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was x-rayed, and the proximal inner was prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
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Brand Name
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Type of Device
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 Key17509869
MDR Text Key320880775
Report Number2124215-2023-38985
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876748
UDI-Public08714729876748
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0031219147
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
HI-TORQUE SUPRA CORE .035, ABBOTT; HI-TORQUE SUPRA CORE .035, ABBOTT
Patient Outcome(s) Required Intervention;
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