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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-500-35
Device Problems Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline failed to open and became stuck in the middle of the phenom catheter during resheathing. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ica. The max diameter was 20mm, and the neck diameter was 10mm.  the patient's vessel tortuosity was severe. The landing zone was 4. 5mm distal and 4. 7mm proximal. The access vessel was the right ica, which was 4. 7mm in diameter. It was reported that the pipeline did not open distally in the first attempt, and it was stated that the middle of the pipeline failed to open. Attempts were made to deploy it. It was observed that after certain point it was not going out of the catheter. Thedevice was resheathed and tried unsheathed again. It was observed that the device was stuck in the delivery catheter.  the device was not placed in a bend and less than 50% had been deployed when the pipeline failed to open. No additional steps were taken to open the device. It was noted that the pipeline and catheter were damaged. The pipeline and catheter were removed from the patient and replaced.  angiographic results post procedure showed slow flow in the aneurysm.  the patient did not experience any injury or complications. The devices were prepared and flushed according to the instructions for use (ifu).
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key11676312
MDR Text Key248840155
Report Number2029214-2021-00441
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
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 07/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-35
Device Catalogue NumberPED2-500-35
Device Lot NumberA990209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2020
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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