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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-500-12
Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2020
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 5. 0x12 pipeline device was introduced to the vessel distal to the aneurysm. However, the distal portion of the stent would not open after several attempts. The stent was removed, and during retrieval, the delivery pushwire separated from the implant near the hub of the phenom 27 microcatheter. The stent was removed along with the catheter, and replacement products were used to complete the procedure. It was noted the physician used significant force to remove the pipeline due to resistance in the hub of the catheter, and was unknown if there was any damage to the catheter. 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. Post-procedure angiography showed an implanted pipeline with good apposition and coverage of the neck of the aneurysm. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left cavernous segment of the internal ca rotid artery with a max diameter of 12 mm and a 5 mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown. Ancillary devices include a neuron max sheath, phenom plus guide catheter, phenom 27 microcatheter.
 
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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 Key10733736
MDR Text Key213003782
Report Number2029214-2020-01055
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00847536016897
UDI-Public00847536016897
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
Report Date 10/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2022
Device Model NumberPED-500-12
Device Catalogue NumberPED-500-12
Device Lot NumberA914817
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 Received10/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/15/2019
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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