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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-375-10
Device Problems Break (1069); Positioning Failure (1158)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/01/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline pushwire that broke after difficulty positioning the pipeline. The patient was undergoing a procedure to pipeline implantation to treat two unruptured aneurysms in the left internal carotid artery (ica), one fusiform and on amorphous. Vessel tortuosity was severe. Dual antiplatelet treatment (dapt) was administered with pru level of 42. It was reported that the pipeline and all accessory devices were prepared per the instructions for use (ifu). The pipeline (model: ped-375-10, lot: b158894) was delivered and deployed. It was recaptured once to reposition. Thepipeline was then deployed in the correct location. Once deployed, the phenom microcatheter was brought through the pipeline to capture the delivery system and the tip coil. However, it was discovered that the delivery system, from the tip coil to the proximal marker, had detached from the delivery wire. The physician attempted unsuccessfully to snare the proximal portion. Several attempts were then made to snare the ptfe sleeves and bring it through the pipeline. Finally the tip coil went through the pipeline and into the ica. The core remained as a loop within the deployed pipeline with the tip coil extending into the ica. A second pipeline (model: ped2-425-25, lot: b197249) was then delivered and deployed to tack down the remaining wire segment. A balloon angioplasty was then performed with great wall apposition achieved with the second pipeline. Post-procedure angiography showed normal blood flow throughout the brain.
 
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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 Key12425231
MDR Text Key270501973
Report Number2029214-2021-01111
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-375-10
Device Catalogue NumberPED-375-10
Device Lot NumberB158894
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 Received09/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/09/2021
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: 09/03/2021 Patient Sequence Number: 1
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