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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-350-20
Device Problems Positioning Failure (1158); Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline that failed to achieve successful wall apposition and was found to be damaged. The patient was undergoing a procedure for flow diversion treatment of an unruptured saccular dissecting aneurysm of a posterior communicating artery. The aneurysm max diameter was 5mm and the neck diameter was 4mm. The vessel tortuosity was minimal. Dual antiplatelet treatment (dapt) was administered. It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu). After the catheter was in place, the pipeline was pushed out but could not be secured. The device was recovered redeployed but still could not achieve full apposition. The pipeline was withdrawn and the tip of the pipeline was noted to be rough. The pipeline was replaced by another with the same diameter which was successfully implanted to complete the surgery. There were no patient symptoms or complications associated with this event. Post-procedure angiography after implantation of the replacement pipeline showed blood retention in the aneurysm. Additional information received clarified that the pipeline could open, but could not fully open. The pipeline had been placed in a straight blood vessel and not a bend at the time. There had been no friction/difficulty during delivery.
 
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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 Key12230238
MDR Text Key264166750
Report Number2029214-2021-00932
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-350-20
Device Catalogue NumberPED-350-20
Device Lot NumberB165628
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2021
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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