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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-30
Device Problems Unintended Ejection (1234); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the catheter and stent were prepared per the instructions for use (ifu). However, the pipeline stent could not be pushed normally due to resistance in the proximal segment of the marksman microcatheter. There was no injury to the patient reported as a result of the event. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right cavernous sinus with a max diameter of 25. 4 mm and a 9. 5 mm neck diameter. It was noted the patient's vessel tortuosity was normal. Dual antiplatelet therapy (dapt) was administered. Additional information received indicated there was no damage to the pushwire or catheter observed. A continuous flush had been administered during the procedure. The stent couldn't be fully retrieved and the stent was separated from the delivery guidewire. The entire system was withdrawn and the surgery was rescheduled.
 
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Brand NamePIPELINE FLEX
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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11047303
MDR Text Key222856979
Report Number2029214-2020-01348
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 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-30
Device Catalogue NumberPED-500-30
Device Lot NumberB035399
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2020 Patient Sequence Number: 1
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