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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-475-20
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding four pipeline devices that failed to open. The patient was undergoing a flow diversion procedure to treat an unruptured saccular aneurysm of the cavernous segment of an internal carotid artery (icu). The aneurysm max diameter was 14mm and the neck diameter was 8mm. The patient's vessel tortuosity was severe. Dual antiplatelet treatment (dapt) was administered with noted pru level of 160. It was reported that after 2 pipeline 5 x 25mm and 1 pipeline 4. 75 x 30mm devices had been tried, failed to open, and removed, the physician made a fourth attempt to implant a flow diverter with a 4. 75 x 20mm pipeline (model: ped-475-20, lot: a896153). The physician began to deploy the pipeline in the distal cavernous segment and the distal end of the pipeline opened successfully. More than 50% of the device was deployed but as the physician neared the proximal third of the device, a twist in the pipeline was noted about 5mm distal to the resheathing pad. The proximal and middle sections of the pipeline were positioned in a vessel bend. The device was resheathed and redeployed 3 times. The physician also attempted "wagging" and deploying in a different location, but the twist of the proximal end remained and the device could not be fully opened. Finally this pipeline was removed together with the phenom-27 microcatheter. It was indicated that all devices were prepared per the instructions for use. No pipeline was implanted. There were no patient symptoms or complications reported related to the event. Post-procedure angiography revealed no issue. The aneurysm remained unruptured and there was no evidence of damage from the devices. Ancillary devices: terumo 6f slender sheath, benchmark 071 90cm intracranial access guide catheter, sofia 5f distal access guide cat heter, synchro2 soft 200cm 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11047609
MDR Text Key225565517
Report Number2029214-2020-01353
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 03/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-475-20
Device Catalogue NumberPED-475-20
Device Lot NumberA896153
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2019
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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