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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT Back to Search Results
Model Number PED-450-25
Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2020
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex has not been returned for evaluation; product analysis cannot be performed. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the flow diverter distal pushwire tip was stuck at the microcatheter hub. The flow diverter was removed, examined, rinsed, and attempted to push the flow diverted distal tip in again two more times. On the third try, the tip passed the hub and entered the microcatheter approximately 1-2 inches and could not be pushed or pulled anymore. The flow diverter was removed, and the distal tip was found kinked and broken. A new flow diverter was used to complete the procedure. No patient injury was reported as a result of the event. The patient was undergoing embolization treatment of a large unruptured saccular aneurysm measuring 28mm x 7mm located in the cavernous segment of the right internal carotid artery (ica). The distal and proximal landing zone was 3. 56mm x 4. 60mm. The vasculature was normal in tortuosity. It was unknown if the patient was on dual antiplatelet therapy. There are no images for review. Post procedural angiography showed the aneurysm was embolized.
 
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Brand NamePIPELINE FLEX
Type of DeviceLASER THERAPY PRODUCT
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10222270
MDR Text Key197931005
Report Number2029214-2020-00645
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-25
Device Catalogue NumberPED-450-25
Device Lot NumberA997340
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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