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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 PED2-400-16
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
Event Type  malfunction  
Event Description
Medtronic received a report that upon advancing the pipeline into the microcatheter, the device became occluded in the proximal portion of the microcatheter. The operator stopped advancement as soon as the resistance was felt. The operator attempted to retract the pipeline where upon the distal portion separated from the proximal portion. The distal portion became stuck in the hub of the microcatheter. The catheter was flushed continuously with heparinized saline. The physician released the loan (slack) in the system in an attempt to resolve the issue, however, the issue was unresolved. It was unknown if the catheter was damaged. The push wire was damaged as the stent detached at the distal section. The pipeline was prepared as indicated in the ifu and it was not used off-label. Ancillary devices include: phenom 27, 150cm microcatheter and a phenom plus guide catheter.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13925201
MDR Text Key291964320
Report Number2029214-2022-00493
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00763000284343
UDI-Public00763000284343
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-400-16
Device Catalogue NumberPED2-400-16
Device Lot NumberB295255
Was Device Available for Evaluation? No
Date Manufacturer Received03/27/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/09/2021
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: 03/27/2022 Patient Sequence Number: 1
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