MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-425-14

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

Patient Problems Intracranial Hemorrhage (1891); Convulsion/Seizure (4406)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the patient experienced a hemorrhage following a pipeline procedure.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left ica.The max diameter was 4mm, and the neck diameter was 3mm.The patient's vessel tortuosity was moderate.The landing zone was 4.1mm distal and 4.2mm proximal. dual antiplatelet treatment was administered, and the pru level was 7.It was reported that there were no issues with device preparation or deployment, and technically the procedure went great.As the patient was waking up from anesthesia they started to seize.They were not waking up, and experienced several seizures through out the next 24 hours.Post procedure ct and mri were clean at 6 hours.A repeat mri at 24 hours showed hemorrhage.The patient had not woken since, having spontaneous movement but was non responsive. the devices were prepared according to the instructions for use (ifu).Ancillary devices include a ballast 088 sheath, phenom plus guide catheter, phenom 27 microcatheter, and synchro 14 guidewire.

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 was received indicating the patient woke after 14 days and was doing well.The patient discharged from the hospital.There were no additional medical/surgical interventions performed.The cause of the hemorrhage was not determined, however, it was indicated that the hemorrhage was 48 hours post-procedure, not 24 hours, as it was initially reported.The patient did have pre-existing lupus.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13636238
• MDR Text Key: 289200968
• Report Number: 2029214-2022-00329
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284428
• UDI-Public: 00763000284428
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED2-425-14
• Device Catalogue Number: PED2-425-14
• Device Lot Number: B299580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Date Device Manufactured: 11/16/2021
• 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
• Patient Age: 41 YR
• Patient Sex: Female