MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PHENOM; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-FG

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

Patient Problems Aspiration/Inhalation (1725); Stroke/CVA (1770); Encephalopathy (1833); Intracranial Hemorrhage (1891); Sepsis (2067); Respiratory Failure (2484); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577)

Event Date 01/26/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a patient who underwent a thrombectomy procedure to treat acute cerebrovascular accident (cva) with right middle cerebral artery (mca) occlusion, subocclusion thrombus of the right internal carotid artery (ica) bifurcation.An 8 french dilator was utilized in the right common femoral artery.The 9 french boss catheter was then introduced into the descending thoracic aorta over the 035 glidewire under visualization.Next the diagnostic catheter and glide were introduced into the boss.Under roadmap guidance the catheter was navigated into the right common carotid artery and then advanced into the right internal carotid artery.The boss was then advanced over the diagnostic catheter and then diagnostic catheter and glide were removed.Subsequent run showed occlusion right middle cerebral artery occlusion, m2 segment.Next, a triaxial system consisting of react, phenom27, and fathom were introduced, and under roadmap guidance, the react was placed in the cavernous segment.The occlusion was crossed with microwire and microcatheter without difficulty.The react was brought to the proximal part of the clot while aspirating.The system was then removed under aspiration.Angiographic runs revealed recanalization of the mca, tici2b.Given the presence of a right ica thrombus at the bifurcation, the guide catheter was removed under aspiration and a large thrombus was removed from the right internal carotid artery bifurcation.Subsequent run revealed recanalization of the internal carotid artery without distal occlusion.There were no device malfunctions or intra-operative issues noted and no immediate complications were noted.Post-operatively, the patient complained of headache.Computed tomography (ct) less than 24 hours after the procedure revealed evolving nonhemorrhagic infarct in the right frontal lobe with loss of gray-white matter differentiation.Vasogenic edema identified in the right frontal lobe.Minimal right to left midline shift was identified.No additional procedure was done.On (b)(6) 2021, the patient was noted to have decreased responsiveness and level of consciousness (loc) so repeat ct was done with no change of mass effect and midline shift observed.It was also suspected the patient may have been experiencing some seizure activity.However, electroencephalogram (eeg) did not reveal any epileptic discharges but rather suggestive severe cerebral dysfunction of the right hemisphere consistent with moderate encephalopathy.The suspected seizures were treated with medication - ativan.The patient became more obtunded and was intubated.Chest imaging revealed right lower lobe infiltrate thought to possibly be due to aspiration.It was also noted in blood cultures that the patient had sepsis of unknown source and was treated with broad-spectrum antibiotics.The patient died on (b)(6) 2021.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that ct imaging on (b)(6) 2021 showed a wedge-shaped area of hypodensity consistent with acute infarct in the right frontoparietal lobe extending to the cortex, however now with sparing of the gray matter and subarachnoid hemorrhage with edema, mass effect and effacement of the cortical sulci, right lateral and third ventricles and 0.8cm midline shift from right to left increased from 0.4cm on prior study.The patient's death occurred after the study period, and was adjudicated as stroke progression (index stroke and not new stroke) not related to the device and not related to the index procedure.

• Brand Name: PHENOM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12713849
• MDR Text Key: 278891480
• Report Number: 2029214-2021-01351
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-FG
• Device Catalogue Number: UNK-NV-FG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• 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): Hospitalization; Required Intervention; Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 122 KG