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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 Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2021
Event Type  malfunction  
Event Description
It was reported that the delivery system was torn.A 7mm x 80mm x 75cm eluvia drug-eluting vascular stent system was selected for use in an angioplasty retrograde procedure to treat stenosis in the femoral arteries.The eluvia stent was implanted correctly.Upon removal of the delivery system, it was noted that the shaft was torn.The procedure was successfully completed with this device.No patient complications were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this eluvia drug-eluting vascular stent system was analyzed.Visual examination revealed a kink to the outer sheath at the nosecone.The outer sheath is buckled 30.2cm from the nosecone.The outer sheath is torn longitudinally from 5mm to 7.4cm from the distal end of the outer sheath.The pull rack is separated inside the handle.Microscopic examination revealed no additional damages.The handle was opened and no additional damage was found.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the sheath is torn.
 
Event Description
It was reported that the delivery system was torn.A 7mm x 80mm x 75cm eluvia drug-eluting vascular stent system was selected for use in an angioplasty retrograde procedure to treat stenosis in the femoral arteries.The eluvia stent was implanted correctly.Upon removal of the delivery system, it was noted that the shaft was torn.The procedure was successfully completed with this device.No patient complications were reported.
 
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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
MDR Report Key11590176
MDR Text Key243179664
Report Number2134265-2021-03983
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/22/2021
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0024502792
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
Date Manufacturer Received06/10/2021
Patient Sequence Number1
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