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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 Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2023
Event Type  Injury  
Event Description
It was reported that the stent was stretched, and three additional stents were required to adequately treat the lesion.An eluvia drug-eluting vascular stent system, 6x150, 130 cm, was selected for use in the endovascular therapy procedure.The target lesion was located within the superficial femoral artery and was reported to be 100% stenosed with severe calcification and tortuosity.From the time the eluvia was inserted into the guide sheath, there was difficulty advancing.When the eluvia reached the target lesion, a strong force was necessary to rotate the thumbwheel.The pull grip was used to complete deployment.Once deployed, it was observed that the eluvia was stretched.In order to adequately treat the target lesion, three additional non-boston scientific stents were placed within the stretched eluvia.The procedure was completed, and there were no reported patient complications.
 
Manufacturer Narrative
Device analysis: returned product consisted of an eluvia self-expanding stent system stuck inside an unknown sheath.The outer sheath, tip, inner shafts, and the remainder of the device were checked for damage.Visual examination revealed that the inner liner was kinked at the proximal end of the nosecone.The middle sheath was separated from the retainer.The inner liner was separated from the clip.The outer sheath was kinked at the nosecone and 24.5 cm from the nosecone.The returned portion of the stent was damaged and separated.The sheath was x-rayed, and the proximal end of the stent was visible inside the sheath.The stent appeared to have separated and partially deployed.The handle, pull rack, thumbwheel, clip, retainer, and distal end of the separated stent were all missing.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to deployment issues, difficulty to advance, and stent deformation.
 
Event Description
It was reported that the stent was stretched, and three additional stents were required to adequately treat the lesion.An eluvia drug-eluting vascular stent system, 6x150, 130 cm, was selected for use in the endovascular therapy procedure.The target lesion was located within the superficial femoral artery and was reported to be 100% stenosed with severe calcification and tortuosity.From the time the eluvia was inserted into the guide sheath, there was difficulty advancing.When the eluvia reached the target lesion, a strong force was necessary to rotate the thumbwheel.The pull grip was used to complete deployment.Once deployed, it was observed that the eluvia was stretched.In order to adequately treat the target lesion, three additional non-boston scientific stents were placed within the stretched eluvia.The procedure was completed, and there were no reported patient complications.It was further reported that a non-boston scientific guidewire was used in conjunction with the eluvia.Additionally, the target lesion was both pre- and post-dilated, and the eluvia was reported to have stretched by approximately 5 cm.
 
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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 Key18016540
MDR Text Key326676428
Report Number2124215-2023-59371
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,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0031008995
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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