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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-450-18
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that pipeline pushwire broke off during the procedure. The patient was undergoing embolization treatment for a small unruptured saccular right internal carotid aneurysm it was reported that after deploy pipeline completely, the physician push marksman to capture the tip coil of delivery system but when microcatheter went to ptfe sleeves this is so difficult to advance more. The physician feels if continue to push the tip coil will separate from delivery system then luckily, he pull out whole system (delivery system and microcatheter). When remove system out of patient, he tried pulling the push wire of pipeline then the tip coil was removed. There were not any patient symptoms or complications associated with this event. Image available for review. The patient¿s blood flow was normal. The vessel was minimal tortuous. No patient injury was reported. Reported device and any accessory devices were prepared as indicated in the ifu. The angiographic result post procedure was normal. Neuro max 088, navien, marksman 150, transend guidewire.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key9137868
MDR Text Key180605399
Report Number2029214-2019-00966
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
P100018.S004
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 09/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-450-18
Device Catalogue NumberPED2-450-18
Device Lot NumberA850792
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/19/2019
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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