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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-500-35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Visual Disturbances (2140)
Event Date 03/13/2016
Event Type  Injury  
Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. Please refer to mdr#s for the other two devices. 2029214-2020-00652, 2029214-2020-00653. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that patient experienced adverse event of mass effect deterioration (main symptom), headache, and eye movement disorder a few days after patient had three medtronic flow diverters implanted. There were no issues with the pipelines. The first flow diverter (ped-375-35) was implanted. The second flow diverter (ped-475-35) was implanted to overlap the first one and the third flow diverter (ped-500-35) was implanted to overlap the second. The severity of the adverse event was not serious, and the patient was confirmed to have recovered approximately 1 year later. There was causal relationship with the equipment and procedure as it could not be denied. Prior to the event, it was reported the target aneurysm was discovered incidentally while treating headache and cranial neuropathy. The patient was undergoing embolization treatment of a saccular aneurysm measuring 35 mm diameter and neck (unknown dimensions) located in the cavernous sinus segment of the right internal carotid artery (ica). The patient was on dual antiplatelet therapy regimen of aspirin and clopidogrel administration. The patient did not have any optic nerve symptoms but did have mass effect (iii-iv disorder). The mrs (modified rankin scale) rated was 1: although there were symptoms, no obvious disability: it is no problem to perform daily work and activities. Post procedure during the 7-month follow up, the mass effect (iii-vi disorder) deteriorated. The corrected mrs rating was 2. For the 1 month and 2-year follow up, there was no treatment. For the 1-year follow up, it was observed that the mass effect (iii-vi disorder) was still there but improved. The corrected ranking scale was 1. For 3-years follow up after the treatment, the mass effect (iii-vi disorder) was still there but no change. Corrected rankin scale rating was 1.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10228643
MDR Text Key201251385
Report Number2029214-2020-00654
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/10/2018
Device Model NumberPED-500-35
Device Lot NumberA056752
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 Received06/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/03/2020 Patient Sequence Number: 1
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