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

Model Number PED2-425-18

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109); Therapeutic Response, Decreased (2271); Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the patient underwent re-treatment on (b)(6) 2020 for the treated aneurysm due to the residual aneurysm.The patient was hospitalized for more than 24 hours, and then went into endovascular surgical treatment.Post-procedure angiography of the initial implant showed incomplete neck coverage, significant stasis, and raymond and roy class 3 classification.It was stated the patient presented a very interesting situation: chronic occlusion of the left internal carotid artery (ica) and a ruptured aneurysm at the choroidal right ica segment (dorsal choroidal, very close to the ica t).The aneurysm neck was 1-2 mm proximal to the right ica without jailing the anterior communicating (acom) artery or middle cerebral artery (mca).However, the margin for deployment error was very small.It was also noted that because of the difference in arterial diameter, the flow diversion stent (fds) tends to fall and opened below the aneurysm neck level.On a recent follow-up, the pi detected the first fds failed to cover the aneurysm opening and proceeded to add a second fds in the optimal location at that time.It was determined the reported event was probably an index procedure failure, and not related to the device.Post-procedure angiography of the re-treatment showed successful treatment, wall apposition achieved, neck coverage achieved, complete stasis, and raymond and roy class 1 classification.The patient was undergoing surgery for re-treatment of a saccular, previously ruptured aneurysm of the right internal carotid artery c7 with a max diameter of 3.8 mm and a 4.3 mm neck diameter.The aneurysm previously ruptured on (b)(6) 2020 and was treated with coil embolization.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 76 on (b)(6) 2020.

Event Description

Additional information received reported the patient was hospitalized from (b)(6) 2020 to (b)(6) 2020.The adverse event was assessed to be probably related to the disease under study, and not related to the underlying condition or disease.The patient did not experience new or worsening of existing neurological deficits.

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.

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.

Event Description

Additional information received reported that the patient was hospitalized.It was noted that the cause of the event was related to the procedure and not the device.

Event Description

Additional information received reported that the patient had an aneurysm occlusion status of raymond roy class 3 at 1-year follow-up visit on (b)(6) 2021 their previous retreatment on (b)(6) 2020.Furthermore, site has indicated "new or worsening of exis ting neurological deficits (transient (tia) or permanent (stroke, cerebral infarction))" between the retreatment and this follow-up visit.

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.(b)(6) a good faith effort will be made to obtain the applicable information relevan to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received indicating the event was resolved on (b)(6) 2021.

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: 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: 10606471
• MDR Text Key: 209383781
• Report Number: 2029214-2020-00985
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/20/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2020
• Device Model Number: PED2-425-18
• Device Catalogue Number: PED2-425-18
• Device Lot Number: A411849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 11/22/2020; 11/01/2021; 12/07/2021; 01/25/2022
• Supplement Dates FDA Received: 11/24/2020; 11/23/2021; 12/22/2021; 02/20/2022
• Date Device Manufactured: 02/08/2017
• 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: 33 YR
• Patient Sex: Male