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

Model Number FG13160-0615-1S

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

Patient Problems Intracranial Hemorrhage (1891); Renal Failure (2041); Sepsis (2067); Obstruction/Occlusion (2422); Multiple Organ Failure (3261); Ischemia Stroke (4418); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)

Event Date 01/22/2024

Event Type  Death  

Event Description

Medtronic received a report that head computerized tomography (ct) without contrast revealed clinically significant hemorrhagic transformation on (b)(6) 2024.The patient experienced hemorrhagic transformation with mass effect on the right lateral ventricle.Baseline modified rankin scale (mrs) score 0, baseline national institutes of health stroke scale (nihss) 15.Ct revealed resorption of hemorrhagic transformation on (b)(6) 2024.The patient died on (b)(6) 2024.This event was not a recurrent or new stroke.The rationale for relating the adverse event (ae) to the system or procedure was hemorrhagic transformation is a usual complication of stroke, despite final mtici score 2b, not related to procedure.The ae had a causal relationship to the disease understudy, and was not related to an underlying condition or disease.Ae did not result from device deficiency.The site assessed this event as not having caused a congenital anomaly, disability, or medical intervention, and was not considered life threatening.The site assessed this event led to hospitalization and death.The site assessed this event as notrelated to the study device or procedure.The sponsor assessed this event as possibly related to the study procedure.Additional information was received that the hemorrhagic transformation had a causal relationship to the disease under study and noted to be a usual complication of stroke, despite final mtici score 2b, not related to the procedure.It was updated that the event was recovering/resolving and death was marked "n".Additional information was received reporting the patient died in the acute care hospital.It was unknown if there were any medical events/procedures leading up to the patient¿s death.The patient's main diagnosis was right sylvian infarction with m1 occlusion of cardioembolic origin.Multiple complications including cardiac and renal failure and sepsis.Patient died on (b)(6) 2024.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received reported that the site has entered a new ae with ae term ¿multiple organ failure¿ start date (b)(6) 2024 with ae description ¿cardio-renal decompensation + then hepatic later ¿ which led to death on (b)(6) 2024, site further noted ¿right sylvian infarction with m1 occlusion of cardioembolic origin in a context of suspension of anticoagulant therapy for the management of anemia, treated by thrombolysis and thrombectomy with poor.¿.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CATHERA
• 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: 18970281
• MDR Text Key: 338506007
• Report Number: 9612164-2024-01440
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG13160-0615-1S
• Device Catalogue Number: FG13160-0615-1S
• Device Lot Number: 227382246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/08/2024
• Date Device Manufactured: 09/28/2023
• 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): Death
• Patient Sex: Female
• Patient Weight: 53 KG