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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-425-35
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2021
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 open in the middle section and a phenom 27 microcatheter that had resistance. The patient was undergoing a procedure to flow diverter treatment of an unruptured saccular right internal carotid artery (ica) aneurysm. The aneurysm max diameter was 22. 21mm and the neck diameter was 13. 93mm. Vessel tortuosity was moderate. It was reported that the pipeline was delivery by the phenom 27 microcatheter to the intended location. The pipeline could not be opened in the middle section during the process of withdrawing the phenom to release the stent. The physician waited 10 minutes to recover and release again but the pipeline still could not be opened. It was noted the pipeline was more than 50% deployed when the failure to open occurred. There were no additional steps or devices required to open the pipeline. The pipeline was resheathed more than 2 times. The devices were prepared and the catheter flushed as indicated in the instructions for use (ifu). Resistance with the phenom 27 microcatheter was observed and it could not be used to complete the procedure. The phenom catheter was replaced and the pipeline was replaced with a competitor's device to complete the procedure. There was no harm or injury to the patient.
 
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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 Key12546979
MDR Text Key273790513
Report Number2029214-2021-01216
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S033
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 09/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-425-35
Device Catalogue NumberPED-425-35
Device Lot NumberB176540
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/16/2021
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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