MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Neurological Deficit/Dysfunction (1982); Paresis (1998); Seizures (2063)

Event Date 06/01/2019

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Https://doi.Org/10.1016/j.Wneu.2019.03.069 ¿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.Medtronic received the following event through literature review: a (b)(6)-year-old 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 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 de monstrate 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 revealed a mild reduction of cerebral blood flow (cbf) maps in the left ins ular-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.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 de ficiency.Further emergent mri demonstrated slight insular corticaledema 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-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.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL 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 ; 9496801345
• MDR Report Key: 9856429
• MDR Text Key: 193405409
• Report Number: 2029214-2020-00260
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR