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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-350-30
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2019
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. This is a report for a similar device that is not marketed in the us. Suspect medical device - similar device brand name
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pipeline flex w/shield technology model# ped2-350-30 the pipeline flex with shield device has not been returned for evaluation; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the resistance was experienced when the pipeline flex with shield was advanced into the medtronic catheter. The device was advanced about 50% out of the catheter tip when it was decided to be resheathed and removed the device. During the removal of the device, it was noted to be tearing. The flow diverter was broken in the hub of the catheter while retrieving the system. However, the device was completely removed with the catheter. No patient injury occurred.
 
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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 Key8975587
MDR Text Key180572745
Report Number2029214-2019-00903
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 11/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/24/2019
Device Model NumberPED-350-30
Device Lot NumberA349422
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2016
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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