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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 PED2-400-10
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 05/23/2019
Event Type  malfunction  
Manufacturer Narrative
The device was implanted in the patient. Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that 2 pipeline flex with shield (ped2) were used to treat a neck recurrence (2 x 3 x 3mm) of a ruptured and coiled pcoma-aneurysm (initially 8x5x4,5 mm). Catheterization of left ica with triaxial system (neuron max, navien 058, phenom 27, transcend platinum). Based on sim and cure calculations a 4 x 10 mm ped was chosen. Unproblematic initial unsheathing of the device in m1 segment (to release the petals) and re-sheathing. Correct positioning of ped2 in the ica terminus to over cover the neck of the aneurysm. Unsheathing of the device. However, re-sheathing of the delivery wire with the microcatheter proved to be difficult (the wire was aligned against the outer curve of cavernous ica) and was aborted. In the control run, there was distal shortening of the ped2 (pli10) was noticed ¿ resulting in insufficient aneurysm neck coverage. A second device of 4 x 12 mm ped (pli20) was delivered in the same manner, with a slightly distal landing zone. In the last run, there was enough neck coverage.
 
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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
7635263305
MDR Report Key8744557
MDR Text Key149654211
Report Number2029214-2019-00633
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSZ
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 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/03/2019
Device Model NumberPED2-400-10
Device Catalogue NumberPED2-400-10
Device Lot NumberA353334
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/03/2016
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: 06/28/2019 Patient Sequence Number: 1
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