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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 PED2-450-25
Device Problems Break (1069); Activation Failure (3270)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/29/2020
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 in the distal segment. The patient was undergoing treatment for an unruptured, saccular aneurysm. The max diameter was 5. 8mm, and the neck diameter was 3. 2mm. The vessel tortuosity was normal. The landing zone was 4. 0mm distal and 4. 6mm proximal. It was reported that the distal part of the device would not open despite manipulation. The stent was resheathed 4 times in first de livery. Less than 50% of the pipeline had been deployed when it failed to open, and no other steps were taken to open the device. The physician decided to remove the device and pulled back the delivery wire to the proximal ica. They changed their decision and pushed the same device again to the desired location. After the second unsheath they realized that the coil tip remained in the vessel. The pipeline was removed with the microcatheter, but the distal coil remained in the patient. The patient status was said to be alive with no injury, symptoms, or other complications. The devices were prepared according to the instructions for use (ifu). Ancillary devices include a marksman microcatheter.
 
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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 Key11127715
MDR Text Key225561727
Report Number2029214-2021-00021
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
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,Followup,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-450-25
Device Catalogue NumberPED2-450-25
Device Lot NumberB039993
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2020
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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