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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 Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/05/2022
Event Type  malfunction  
Event Description
It was reported that the stent was partially deployed.After pulling the entire system the stent was deployed, however it had stretched.Two 7mm x 120mm, 130cm eluvia drug-eluting vascular stents were selected for use in a stenting procedure in the superficial femoral artery (sfa) as treatment for lower extremity peripheral arterial disease.The vessel was 100 % stenosed and had moderate tortuous severity.During deployment of the additional stent in the proximal sfa, the thumbwheel was stiff and it was difficult to deploy the device.The thumbwheel was turned completely, but the stent could not be deployed by about 4 cm.The guidewire was also stuck in the guide wire lumen, where the remaining part of the stent was deployed by pulling the entire device, but the stent was placed in a slightly stretched state.The delivery system was able to be removed, however there was an observed kink on the shaft at the base of the handle that likely occurred at the time of retrieval.No patient complications were reported.
 
Event Description
It was reported that the stent was partially deployed.After pulling the entire system the stent was deployed, however it had stretched.Two 7mm x 120mm, 130cm eluvia drug-eluting vascular stents were selected for use in a stenting procedure in the superficial femoral artery (sfa) as treatment for lower extremity peripheral arterial disease.The vessel was 100 % stenosed and had moderate tortuous severity.During deployment of the additional stent in the proximal sfa, the thumbwheel was stiff and it was difficult to deploy the device.The thumbwheel was turned completely, but the stent could not be deployed by about 4 cm.The guidewire was also stuck in the guide wire lumen, where the remaining part of the stent was deployed by pulling the entire device, but the stent was placed in a slightly stretched state.The delivery system was able to be removed, however there was an observed kink on the shaft at the base of the handle that likely occurred at the time of retrieval.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system with an unknown 0.014 inch guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were inspected for damage.Visual examination revealed that the sheath is kinked at the nosecone.Microscopic and further examination of the reminder of the device revealed no additional damages.The stent was deployed and did not return for analysis.An x-ray of the handle found the proximal inner was prolapsed.The customer used an undersized guidewire during deployment which led to insufficient support and caused the proximal inner to prolapse.Prolapsing of the proximal inner would cause deployment issues, froze on wire, and damage to the stent if the stent did not fully deploy when the device is pulled out.The information suggested that the kink occurred during removal due to complications during the procedure.
 
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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 Key15509968
MDR Text Key304135489
Report Number2124215-2022-38099
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/18/2024
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0029102124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2022
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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