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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 PED2-400-18
Device Problems Retraction Problem (1536); Migration (4003); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding deployment and device delivery system issues of a pipeline flex with shield. The patient was undergoing an off-label procedure to treat subarachnoid hemorrhage due to a ruptured pseudoaneurysm of a right vertebral artery. The pseudoaneurysm max diameter was 4. 18mm and the neck diameter was 6mm. Vessel tortuosity was minimal. It was reported that all devices were prepared as indicated in the instructions for use (ifu). The pipeline was delivered and deployed without issue. The stent opened well, covering the intended landing zone. However, when trying to recapture the ptfe sleeves into the phenom27 microcatheter, the sleeves would not retract fully back into the microcatheter. The physician ultimately had to remove the phenom27 and the pipeline delivery system with the ptfe sleeves still exposed. This caused the sleeves to catch the distal end of the stent and pull it down from the intended location. A second pipeline then had to be implanted for full coverage. Both pipeline were open and well apposed at the conclusion of the case. There were no patient symptoms or complications associated with this event.
 
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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 Key12337396
MDR Text Key267103507
Report Number2029214-2021-01027
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-400-18
Device Catalogue NumberPED2-400-18
Device Lot NumberB197346
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 Received08/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/27/2021
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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