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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 Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2022
Event Type  malfunction  
Event Description
It was reported that stent partial deployment occurred.The target lesion was located in the superficial femoral artery (sfa).A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use.During the procedure, the first 3/4 of the stent deployed fine.The last few millimeters of the stent were hard to deploy; therefore the physician kind of "walk it back".The stent did finally deploy.The delivery system could not be removed over the guidewire.The delivery system and the guidewire were removed at the same time.The procedure was successfully completed with this device.There were no patient complications.
 
Manufacturer Narrative
D4: lot number, expiration date, unique identifier (udi) #: additional information h4: device manufacture date: additional information.Device evaluated by mfr: the 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 sheath is kinked at the nosecone.The pull rack is separated 11mm from the handle.The proximal section of the pull is missing and did not return for analysis.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.
 
Event Description
It was reported that stent partial deployment occurred.The target lesion was located in the superficial femoral artery (sfa).A 7x120, 130 cm eluvia drug-eluting vascular stent system was selected for use.During the procedure, the first 3/4 of the stent deployed fine.The last few millimeters of the stent were hard to deploy; therefore the physician kind of "walk it back".The stent did finally deploy.The delivery system could not be removed over the guidewire.The delivery system and the guidewire were removed at the same time.The procedure was successfully completed with this device.There were no patient complications.
 
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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 MN
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15221334
MDR Text Key302330858
Report Number2134265-2022-08397
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876731
UDI-Public08714729876731
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 10/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/03/2023
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0027859364
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE: 014 COMMAND WIRE.; GUIDEWIRE: 014 COMMAND WIRE.
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