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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-475-30
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 devices had been tried, failed to open, and removed, the physician made a third attempt to implant a flow diverter with a 4. 75 x 30mm pipeline device (model: ped-475-30, lot: a619493). This device was delivered through the microcatheter and the distal end opened during deployment. However, the pipeline had a twist in the proximal end distal to the resheathing pad. The middle and proximal end of the device were positioned in a vessel bend. More than 50% of the device was deployed when it failed to open. The physician resheathed and deployed the 4. 75 x 30mm pipeline a total of 3 times in different segments of the ica and attempted "wagging" to encourage the pipeline to open, but without success. The pipeline was then resheathed and removed with the microcatheter. 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.
 
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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 Key11047569
MDR Text Key225565497
Report Number2029214-2020-01352
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 Expiration Date03/26/2021
Device Model NumberPED-475-30
Device Catalogue NumberPED-475-30
Device Lot NumberA619493
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 Manufactured03/27/2018
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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