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); Hematoma (1884); Intracranial Hemorrhage (1891); Multiple Organ Failure (3261); Swelling/ Edema (4577)

Event Date 05/14/2021

Event Type  Death  

Manufacturer Narrative

See manufacturer report # 2029214-2021-00797 and 2029214-2021-00798 for other devices used in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information reporting that a patient underwent a combined mechanical thrombectomy procedure to collect thrombus in the left middle cerebral artery (mca) m1 segment.In which a solitaire device, react-68 catheter, and phenom 27 microcatheter were used.The patient's baseline nihss was 17, baseline mtici was 0, and aspect was 8.All devices were prepared as indicated in the instructions for use (ifu) and the catheter was flushed per ifu. no device malfunction or intra-operative issues were reported.Final mtici score was 2c. 24-hour post-procedure computed tomography (ct) on (b)(6) 2021 revealed expansion of the index infarction with mild space-occupying effect 30% or less of the infarcted area (ph1).Nihss at 24-hours post-procedure was 13.Ct performed at discharge on (b)(6) 2021 showed hematoma within the ischemic field with mild space-occupying effect involving more than 30% of the infarcted area (ph2) and "malignant cerebral edema/brain edema".Nihss score at discharge was 13.No additional treatment was noted.Additional information received indicated the patient was discharged (b)(6) 2021 with an modified rankin scale (mrs) score of 4, and baseline nihss was 17.The model/lot # of the phenom microcatheter was not collected in the study.Additional information received reported that ct imaging the day after a solitaire procedure showed expansion of ischemic parenchyma and hemorrhagic transformation in the basal ganglia.The stroke and need for hospitalization lead to aspiration pneumonia and multiple organ failure.The patient's mrs score was 0 and their nihss score was 17.The patient later passed away on (b)(6) 2021.The event was not the result of a device deficiency.The event was assessed as probably related to the disease under study, caused by an underlying condition/disease, not related to the device, and probably related to the procedure.The patient had been undergoing treatment for a clot located in the m1 segment of the left middle cerebral artery.The patient's mtici score pre-procedure was 0, and post-procedure it was 2c.

Manufacturer Narrative

Upon further review, patient code e0704 no longer applies.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 was received indicating that per (b)(6) image read for procedure images, the final tici was 2a.

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.

• 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: 12097458
• MDR Text Key: 259334056
• Report Number: 2029214-2021-00799
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• 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: 11/26/2021
• Date Device Manufactured: 02/15/2020
• 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; Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 90 KG