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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-350-12
Device Problems Break (1069); Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2019
Event Type  malfunction  
Manufacturer Narrative
The device has been returned; however, the investigation has not been completed yet. Once the investigation has been completed, a supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that resistance was felt when retracting the medtronic flow diverter pushwire. Prior to the event, the flow diverter had been successfully implanted. It was during retracting of the pushwire inside the microcatheter in the right common iliac artery region that the reported event occurred. The physician continued to pull the pushwire against a lot of resistance and broke the proximal end of the pushwire inside the microcatheter. The tip was removed with the microcatheter. No patient injury was reported as a result of the event. The patient was undergoing embolization treatment of a ruptured saccular aneurysm measuring 6mm x 3mm located in the left internal carotid artery (ica). The distal and proximal landing zone was 3. 2mm x 3. 8mm. The vasculature was normal in tortuosity. The patient was on dual antiplatelet therapy and there are no images for review.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8725558
MDR Text Key149357072
Report Number2029214-2019-00598
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-350-12
Device Lot NumberA794030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/06/2019
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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