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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 24653
Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2022
Event Type  malfunction  
Event Description
It was reported that the eluvia drug-eluting vascular stent was stretched.During the endovascular therapy treatment in the superficial femoral artery (sfa), the eluvia drug-eluting vascular stent system was selected for use.The target lesion was moderately tortuous and calcified and was 100% stenosed.The target lesion was predilated using a non-bsc balloon catheter.The eluvia drug-eluting vascular stent system was advanced to the target lesion in the sfa and deployment was attempted.There was a strong force necessary to rotate the thumbwheel, but the stent did not deploy.The pull grip was attempted to be utilized, but ultimately did not deploy the stent.The stent was eventually placed, but the proximal side was elongated by 1 cm.An additional eluvia, 7x80 was placed in the target lesion, and the eluvia was post-dilated.The procedure was completed.There were no reported adverse consequences to the patient.
 
Manufacturer Narrative
Initial reporter address 1: (b)(6).Initial reporter state: (b)(6).
 
Event Description
It was reported that the eluvia drug-eluting vascular stent was stretched.During the endovascular therapy treatment in the superficial femoral artery (sfa), the eluvia drug-eluting vascular stent system was selected for use.The target lesion was moderately tortuous and calcified and was 100% stenosed.The target lesion was predilated using a non-bsc balloon catheter.The eluvia drug-eluting vascular stent system was advanced to the target lesion in the sfa and deployment was attempted.There was a strong force necessary to rotate the thumbwheel, but the stent did not deploy.The pull grip was attempted to be utilized, but ultimately did not deploy the stent.The stent was eventually placed, but the proximal side was elongated by 1 cm.An additional eluvia, 7x80 was placed in the target lesion, and the eluvia was post-dilated.The procedure was completed.There were no reported adverse consequences to the patient.
 
Manufacturer Narrative
(b)(6).G2 - report source: user facility removed.Device/media analysis: returned product consisted of an eluvia self-expanding stent system with a non-bsc 0.014 in.Filter 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 sheath was kinked at the nosecone.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.Product analysis found damage that would have contributed to the deployment issue and stent deformation.
 
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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
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 Key15674623
MDR Text Key302448938
Report Number2124215-2022-41848
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/21/2024
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0029292715
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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