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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-425-35
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2020
Event Type  malfunction  
Manufacturer Narrative
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 #
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ped2-425-35 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 after placing the pipeline flex with shield and retrieving the delivery system, resistance was felt with the sleeves. The distal section of the pushwire fractured within the catheter. The whole system was retrieved, and nothing was left within the patient. The vessel anatomy was reported to have been moderate in tortuosity. No patient injury occurred. The devices were used per the instructions for use (ifu). The catheter was use flushed per the ifu. The patient was treated for right internal carotid (ic) c3, unruptured, saccular aneurysm. The max diameter was 13 mm. The neck diameter was 6 mm. The distal landing zone was 4. 28 mm and proximal was 4. 65 mm.
 
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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
9496801345
MDR Report Key9865787
MDR Text Key202536750
Report Number2029214-2020-00279
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 03/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/12/2022
Device Model NumberPED-425-35
Device Lot NumberA847636
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/13/2019
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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