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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 Problem Neurological Deficit/Dysfunction (1982)
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis as it was implanted in the patient. Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. The reported events are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu). Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure related event. The exact cause is unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report through literature review of ¿arterial spin labeling magnetic resonance imaging to diagnose contrast-induced vasospasm after intracranial stent embolization¿ (daniele giuseppe romano, giulia frauenfelder, gianpiero locatelli, maria pia panza, alfredo siani, salvatore tartaglione, sara leonini, bruno beomonte zobel, renato saponiero). Contrast-induced encephalopathy (cie), also known as iodinated contrast encephalopathy, is a rare and misdiagnosed complication of intravascular injection of iodinated contrast. Neurotoxicity from iodinated contrast agents leads to neurologic deficits, which may mimic acute stroke or transient ischemic attack. Although the underlying mechanism of injury is not well understood, it has been postulated that a combination of chemotoxic effects from contrast hyperosmolarity together with direct neurotoxicity of the contrast agent itself are responsible for arterial vasospasm, cortical edema, and neurologic effects. Case report: a (b)(6) woman with a history of hypertension and endovascular coil embolization of a 5-mm ruptured right supra-ophthalmic internal carotid artery aneurysm 6 months previously underwent a follow-up angiography, which demonstrated a recanalization of the treated aneurysm, with a 3-mm neck. The patient underwent elective flow-diverter (pipeline 3. 75_18 mm) embolization of the recanalized supra-ophthalmic internal carotid artery aneurysm, with no periprocedural complications. At 4 hours post procedure, the patient acutely developed sensitive aphasia and right arm paresis. Emergent no-contrast ct did not demonstrate any acute ischemic or hemorrhagic cerebral foci. Moreover, emergent mri did not show any acute foci of restricted diffusion or subcortical edema in flair or vascular abnormality in reconstructed 3-dimensional time-of-flight sequences. As functional imaging, 3- dimensional asl turbo gradient spin echo sequence (ultra-fast, single-shot continuous proton labeling; slice thickness 3 mm; repetition time 5000 milliseconds; echo time 16. 4 milliseconds) revealed a mild reduction of cerebral blood flow (cbf) maps in the left insular-temporal-parietal anterior lobe; because we suspected arterial vasospasm due to iodinated contrast injection, the patient underwent emergent dsa, but no signs of distal vasospasm were documented (figure 2). 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 respectively in flair and dwi sequences, 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 administered. 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-temporal parietal 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 post procedural 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 Key8772269
MDR Text Key150542321
Report Number2029214-2019-00698
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
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 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
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 Received06/13/2019
Was Device Evaluated by Manufacturer? No
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: 07/09/2019 Patient Sequence Number: 1
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