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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-400-14
Device Problems Break (1069); No Apparent Adverse Event (3189)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline pushwire came loose from the device. The patient was undergoing surgery for treatment of a saccular, previously ruptured aneurysm of the right posterior communicating (pcom) artery with a max diameter of 4. 5 mm and a 4 mm neck diameter. It was noted the patient's vessel tortuosity was minimal. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 126. It was reported that the pipeline was advanced through the phenom microcatheter which was distal in the m2 region. The pipeline was then unsheathed in the m1 region and slowly dragged back to the terminus landing zone. During the drag process, the distal end of the pipeline opened. The physician wanted to advance the pipeline distally since they pulled the pipeline down too proximal. The phenom was advanced with a slight pull on the pushwire to recapture the pipeline. Under fluoro, it was noticed the pushwire had no friction and came loose from the device. Since the pipeline had only been deployed about 2-3 mm, the pipeline and microcatheter were removed. There was no vessel injury, and another device was used to complete the procedure. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Ancillary devices include a 9f terumo pinnacle, ballaste 90cm 6f, 072 navien, headway duo 156cm, phenom 27 150cm, syncro2 soft, target xl 5x10 360.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10551747
MDR Text Key207529503
Report Number2029214-2020-00944
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 12/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-14
Device Catalogue NumberPED-400-14
Device Lot NumberA894611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/09/2019
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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