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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 Problem Premature Activation (1484)
Patient Problem No Patient Involvement (2645)
Event Date 09/25/2019
Event Type  malfunction  
Event Description
It was reported that the stent inadvertently deployed.A 7x80x130 cm eluvia drug-eluting vascular stent was selected for implantation in the left superficial femoral artery.During preparation of the device and before use inside the patient, the stent was inadvertently partially deployed upon removal of the device from the packaging.Approximately 3-5 mm of the stent was unsheathed and flared.The inadvertent deployment was noticed immediately, so the device was exchanged for a new device which was then successfully used.The patient experienced no adverse effects and everything was fine.
 
Event Description
It was reported that the stent inadvertently deployed.A 7x80x130 cm eluvia drug-eluting vascular stent was selected for implantation in the left superficial femoral artery.During preparation of the device and before use inside the patient, the stent was inadvertently partially deployed upon removal of the device from the packaging.Approximately 3-5 mm of the stent was unsheathed and flared.The inadvertent deployment was noticed immediately, so the device was exchanged for a new device which was then successfully used.The patient experienced no adverse effects and everything was fine.
 
Manufacturer Narrative
Device analysis by mfr: the returned product consisted of an eluvia self-expanding stent system.Visual examination revealed that the stent is partially deployed approximately 6mm from the distal end of the middle sheath.There is a kink to the outer sheath at the nosecone, 2.8cm and 41.4cm from the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured position.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
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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 Key9191469
MDR Text Key164133976
Report Number2134265-2019-12424
Device Sequence Number1
Product Code NIU
UDI-Device Identifier08714729876717
UDI-Public08714729876717
Combination Product (y/n)N
PMA/PMN Number
P180011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24657
Device Catalogue Number24657
Device Lot Number0023375928
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2019
Date Manufacturer Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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