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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-375-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); Paresis (1998); Seizures (2063)
Event Date 03/15/2019
Event Type  Injury  
Manufacturer Narrative
The pipeline device will not be returned for evaluation as it was implanted in the patient. Based on the reported information, there does not appear to have been any defect of the device during use. The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Romano, d. G. , frauenfelder, g. , locatelli, g. , panza, m. P. , siani, a. , tartaglione, s. , saponiero, r. (2019). Arterial spin labeling magnetic resonance imaging to diagnose contrast-induced vasospasm after intracranial stent embolization. World neurosurgery, 126, 341-345. Doi:10. 1016/j. Wneu. 2019. 03. 069. Medtronic literature review found a report of patient symptoms after pipeline flex implantation. The patient underwent pipeline flex in the treatment of a recanalized, right supra-ophthalmic internal carotid artery aneurysm. The aneurysm had a 3mm neck. The aneurysm had previously been coiled. There were reportedly no periprocedural complications. At 4 hours post-procedure, the patient acutely developed sensitive aphasia and right arm paresis. Imaging revealed a mild reduction of cerebral blood flow (cbf) maps in the left insular-temporal-parietal anterior lobe. The physicians suspected arterialvasospasm; the patient underwent emergent dsa, but no signs of distal vasospasm were documented. Intravenous dexamethasone and hydration was started in suspicion of irritative cortical edema. At 16 hours, patient experienced epileptic seizure, global aphasia, right hemiparesis, left gaze deviation, and vii cranial nerve deficiency. Further emergent mri demonstrated slight insular cortical edema and corresponding slight restricted diffusion, with reduced distal left middle cerebral artery canalization compared with the contralateral hemisphere in time of flight; additional asl perfusion study confirmed low cbf values, supporting a neurotoxicity condition with secondary vasospasm. Emergent dsa, with a total of 12 ml of iodinated-contrast injection, confirmed distal vasospasm of left middle cerebral artery territories; intra-arterial infusion of 2. 5 mg nimodipine was started. After angiography, intravenous therapy with nimodipine infusion (5 ml/h over 8 hours) mannitol (1. 5 g/kg infused over 60 minutes), dexamethasone (10 mg, then 4 mg every 6 hours, gradually reduced in 2 days) and hydration was ad ministered. Intravenous therapy was continued for the following hours. The patient gradually improved to complete neurologic recovery within 48 hours of symptom onset, with no changes in follow-up, conventional mri, but with significant normalization in cbf maps from the insular-temporalparietal anterior lobe region. The patient was discharged 6 days later. A 3-week follow-up mri confirmed a complete left hemisphere restored perfusion, with no postprocedural ischemic/hemorrhagic outcomes.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8694222
MDR Text Key147859113
Report Number2029214-2019-00544
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-375-18
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 Received05/15/2019
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: 06/12/2019 Patient Sequence Number: 1
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