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

Model Number PED2-400-16

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

Patient Problems Paresis (1998); Vasoconstriction (2126); Dysphasia (2195); Hydrocephalus (3272); Thrombosis/Thrombus (4440)

Event Date 06/02/2020

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 had experienced a subarachnoid hemorrhage.It was stated the event was not related to the procedure and device, but per the initial assessment, the adverse event was related to the procedure and dual antiplatelet therapy (dapt) therapy.Medical and surgical treatment was provided, and the patient was in a recovering/resolved status at the time of the report.Post-procedure angiography showed a successful implant of the pipeline, wall apposition and neck coverage achieved, complete nd the raymond roy class 1 occlusion.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left c5 internal carotid artery with a max diameter of 9.45 mm and a 7.26 mm neck diameter.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 119.Ancillary devices include a phenom 17 microcatheter.Additional information received reported that the subarachnoid hemorrhage was related to a second procedure performed on the right i nternal carotid artery with a non-study, non-medtronic device for elective r/ca coiling + silk flow diverter, complicated with in stent thrombosis and small distal mca thrombosis.Prior to the second procedure on (b)(6) 2020 the patient was noted to have new neurological deficits, right facial droop, slurred speech, and left side plegia.The patient was taken immediately back to the or, and angio showed a sub occlusive thrombus in the stent proximal section and in the middle, and distal small embolus in the pericallosal and parietal mca branch.The patient was given heparin and integrilin, and regained their baseline exam.Additionally, it was noted that there was stagnation of contrast within the carotid artery secondary to vasospasm in the cervical carotid, for which 10 mg of intra-articular verapamil was slowly administered.A ct scan on (b)(6) 2020 showed the subarachnoid hemorrhage, and another ct scan 6.5 hours later also showed hydrocephalus and an intraventricular hemorrhage.On (b)(6) 2020 the patient was intubated and had a sip lumbar drain inserted.Tcd imaging that day showed vasospasm in both the right and left mca.The site and sponsor assessed the subarachnoid hemorrhage as not related to pipeline device and procedure as the aneurysm responsible for it was not treated with a medtronic 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 reported that the patient was taken back to or.A sub-occlusive thrombus in stent proximal margin and in the middle was discovered.It was noted that this event is not related to the inspire medtronic 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 correcting that patient out come was noted to be recovered/event resolved on (b)(6) 2020.The event of post-operative subarachnoid hemorrhage (sah) is considered to be associated with dapt and not related to the medtronic device or index procedure.

• 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: 13635793
• MDR Text Key: 289200906
• Report Number: 2029214-2022-00328
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

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 Expiration Date: 05/03/2021
• Device Model Number: PED2-400-16
• Device Catalogue Number: PED2-400-16
• Device Lot Number: A640483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 06/27/2022; 01/19/2024
• Supplement Dates FDA Received: 07/20/2022; 02/14/2024
• Date Device Manufactured: 05/04/2018
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Female