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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 Paralysis (1997); Dyskinesia (2363); Partial Hearing Loss (4472)
Event Date 04/26/2021
Event Type  Injury  
Manufacturer Narrative
Physician information is not reported due to region privacy laws. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information reporting that a patient who underwent a procedure for pipeline implantation had post-procedure complications. The patient's mrs pre-procedure was 3. Post-procedure mrs was 4. It was reported the patient had trunk ataxia, facial paralysis, and hearing loss post-procedure. The aneurysm was discovered after the patient experienced cranial nerve disorder and neurological symptoms with no prior history. An unruptured spindle-shaped aneurysm of the left vertebral artery with a max diameter of 47. 7mm was observed. The patient underwent a procedure for flow diversion treatment on (b)(6) 2021 with a pipeline (model: ped-500-35, lot: b121666). Neurological symptoms were reported to occur on (b)(6) 2021. There was no allegation of any device malfunction or defect. Multiple other pipelines were included in the report information without any allegation; there was no information submitted in the initial information regarding the other pipelines.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12067254
MDR Text Key265204755
Report Number2029214-2021-00775
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 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-500-35
Device Catalogue NumberPED-500-35
Device Lot NumberB121666
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 Received06/17/2021
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: 06/25/2021 Patient Sequence Number: 1
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