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

Model Number UNK-NV-FG

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problems Fatigue (1849); Intracranial Hemorrhage (1891); Paresis (1998); Hydrocephalus (3272); Speech Disorder (4415); Ischemia Stroke (4418); Swelling/ Edema (4577)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

Refer to manufacturer report 2029214-2023-02469 for related device.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

Medtronic received a report that this was a giant m1 aneurysm.Navigation into the outflow of the aneurysm was difficult.Many cathe ter/wire combinations were used to get distal to the aneurysm neck.Once that was achieved the 450x35 device was advanced into position.The distal braid never opened.More than 50% of device was deployed and the braid remained constrained.It was resheathed and d eployed in a different location with the same result.Catheter manipulation failed to get device to open.The tip coil never moved distal to the braid despite multiple recapture attempts.The final recapture the tip coil moved inside the braid and it was apparent that the device was no longer on the deployment mechanism.It was completely within the phenom 27 at this time.The entire catheter and device were removed from the patient.A new phenom 27 was opened and navigated again with great difficulty distal to the aneurysm.A new device 4x30 was deployed successfully from superior branch of m2 back to l carotid terminus.The pipeline was not positioned in a bend.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed more than two times.There were no additional steps or other devices required to open the pipeline.The pipeline was resheathed and removed from the patient with the microcatheter.With in an hour post implant of 2nd device the patient was found to have hemorrhaged intra cranially.The patient was extubated and taken to computerized tomography (ct) after somnolescent behavior.She was found to have subarachnoid hemorrhage.The aneurysm was not actively leaking.There was significant edema and hydrocephalus.Cause of bleed is impossible to determine.External ventrical drainage (evd) planned and patient condition serious.The pipeline was used for an indication that is not approved, location was not in the instructions for use (ifu).The device and any accessories were prepared as indicated in the ifu.The patient is alive with injury.  the patient was undergoing surgery for treatment of a saccular, unruptured left middle cerebral artery (mca) aneurysm with a max dia meter of 22mm and a 14mm neck diameter.The landing zone was 2.0mm distally and 3.2mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) levek 123.Angiographic result post procedure showed successful deployment of pipeline 4x30 with excellent results.Ancillary devices include a penumbra bmx96 guide catheter, prowler plus microcatheter, and synchro, aristotle 24, luge, guidewires.Refer to manufacturer report 2029214-2023-02469 for related device.

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 that the patient was later brought to get an angiogram.The giant aneurysm had rapidly thrombosed, also thrombosing the m1.The patient suffered a large mca territory infarct.The patient experienced aphasia and hemiparesis related to the hemorrhage.In traditional deployment the tip coil advances as the device opens, the tip coil stayed at the distal braid never advancing, there was friction associated with this event.

• 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: 18386678
• MDR Text Key: 331286609
• Report Number: 2029214-2023-02470
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 12/13/2023
• 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): Required Intervention; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 97 KG