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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-500-18
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/20/2020
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 pipeline pushwire broke off in the patient. The patient was undergoing surgery for treatment of a saccular, unruptured, cavernous right ica aneurysm with a max diameter of 9mm, a 5mm neck diameter, and a landing zone of 4. 8x5mm. It was noted the patient's vessel tortuosity was moderate. It was reported that the pipeline was deployed in the m1, and when the physician started to drag the device back, the pushwire broke off from the distal tip proximal to the re-sheathing marker. A snare was used to try and retrieve the wire, but it didn't work. Four atlas stents were placed to cover the wire from the pcom (posterior communicating artery) and into the cavernous section past the pipeline but before the aneurysm. It was indicated that all devices were prepared as per the instructions for use (ifu), and it was stated the patient was doing well. Ancillary devices include a 6fr shuttle sheath, phenom 027 microcatheter, phenom plus guide catheter, and a synchro 2 guidewire.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9622387
MDR Text Key188888745
Report Number2029214-2020-00069
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,Followup
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model NumberPED-500-18
Device Catalogue NumberPED-500-18
Device Lot NumberA808107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2019
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: 01/23/2020 Patient Sequence Number: 1
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