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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-425-30
Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problems Low Blood Pressure/ Hypotension (1914); Stenosis (2263)
Event Date 03/16/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline experienced resistance in the proximal section of the marksman catheter. The devices were replaced, and the patient did not experience any injury or complications. The devices were prepared and flushed according to the instructions for use (ifu). The patient was undergoing treatment for an unruptured, amorphous aneurysm. The max diameter was 6. 34mm, and the neck diameter was 5. 18mm. The patient's vessel tortuosity was severe. The landing zone was 4. 56mm distal and 3. 11mm proximal. The access vessel diameter was 3. 12mm.  dual antiplatelet treatment was administered. Additional information received 2021-03-22 indicated that the patient's blood vessel was extremely tortuous/twisted, and the catheter had accordioned after trying to pass through key parts many times. This caused the pipeline to fail to be delivered during the deployment process. At that time, the patient's blood vessel dropped, and the operation could not be performed. Due to vascular stenosis, only one stryker intracranial stent was used to treat the stenoisis, and the aneurysm operation was not successful. The pipeline pushwire was kinked/separated, but images showed no separation of pushwire.
 
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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 Key11636730
MDR Text Key247662389
Report Number2029214-2021-00407
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-425-30
Device Catalogue NumberPED-425-30
Device Lot NumberB075766
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2020
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: 04/08/2021 Patient Sequence Number: 1
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