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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO PGLA HLX; DEVICE, EMBOLIZATION, VASCULAR
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MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO PGLA HLX; DEVICE, EMBOLIZATION, VASCULAR Back to Search Results
Model Number PV-20-50-HELIX
Medical Device Problem Code Separation Failure (2547)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/10/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received a report that the coil would not be detached when placed in the patient's vessel.As a result it was removed and replaced successfully.It is unknown if the devices were prepared per the ifu, information regarding detachment attempts, patient anatomy are unknown.No further information was provided.Ancillary devices include a renegade stc 2.4f microcatheter.
 
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Brand Name
CONCERTO PGLA HLX
Common Device Name
DEVICE, EMBOLIZATION, VASCULAR
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
MDR Report Key9039451
Report Number2029214-2019-00920
Device Sequence Number16617081
Product Code KRD
UDI-Device Identifier00847536033689
UDI-Public00847536033689
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K090046
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/26/2022
Device Model NumberPV-20-50-HELIX
Device Catalogue NumberPV-20-50-HELIX
Device Lot NumberA855802
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/10/2019
Initial Report FDA Received Date09/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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