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

Model Number PED3-027-450-14

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problems Headache (1880); Intracranial Hemorrhage (1891); Stenosis (2263); Obstruction/Occlusion (2422); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)

Event Date 10/16/2021

Event Type  malfunction  

Event Description

Medtronic received a report that the patient experienced severe headaches and right frontal sulcal hyperdensity 8 days after being i mplanted with a pipeline device, and was hospitalized from (b)(6) 2021 to (b)(6) 2021.Concomitant/additional medical treatment was also given, and the event resolved on (b)(6) 2021.The headaches were said to have resulted in new or worsening of existing neurological deficits.The site assessed the event as possibly related to the device and procedure, and not related to antiplatelet medication.The patient was undergoing treatment for a saccular, sidewall aneurysm located in the c6 segment of the right internal carotid artery.The max diameter was 1mm.Additional information received reported that a balloon was used "to dilate the stent".It was also reported that wall apposition was not achieved, and it is unclear whether this was during the procedure or by the end of the procedure for which the site has been queried.Furthermore, it was reported that when wall apposition was not achieved, it was not due to failure of study device to open.Ct imaging on (b)(6) 2021 showed "probele sulcal subarachnoid hemorrhage right frontal ," which was possibly related to the device and procedure.Concomitant or additional medication was given.Additional information was received indicating there was no device deficiency associated with the headaches.The inability of the stent to adapt to the tortuosity of the vessel and the smaller diameter of the vessel in the part compared to the stent diameter was the cause of the event.The subarachnoid hemorrhage was not related to the device.The adjunctive balloon angioplasty was used to dilate the stent.Additional information was received indicating the use of an additional pipeline vantage was unsuccessful as the deployment of the stent was downstream of the aneurysm neck and it was attempted to squeeze in front of the aneurysm neck which caused the microcatheter to be removed without the stent.An attempt to recover it was not successful and the material was removed.A repat catheterization of the right middle cerebral artery occurred with a phenom 27 on a terumo 12 guide and deployment of a similar 4.5 x 14 stent.In addition, corelab reported greater than 75-100% stenosis at the 6 month follow up dsa imaging on (b)(6) 2022 with the comment "occlusion of the distal ica / stent at the ophthalmic segment.No unsubtracted image to see the fd.The ipsilateral ica ends at the ophthalmic segment.The ophthalmic artery had severe stenosis proximally.No aneurysm inflow from the contralateral ica".Furthermore, it was noted the ipsilateral aca/mca was perfused from the other ica via the aca.Additional information received reported that the first stent used in the procedure was not implanted because of misplacement of the microcatheter position during deployment, which required them to attempt to retrieve the pipeline.Additional information was received indicating there was a small isolated focus of the subarachnoid hemorrhage on the right posterior parietal sulcus.Additional information received clarified that the second pipeline was successfully implanted despite wall apposition not being achieved, and a third pipeline was not used in the procedure.Follow-up mra imaging on (b)(6) 2022 reported that neck coverage was not sufficient with reason "stent occlusion since (b)(6) 2022." additional information received reported that corelab reported >75-100% parent artery stenosis due to thrombosis at the imaging performed on (b)(6) 2022.The patient was asymptomatic.Additionally, the site corrected that neck coverage was achieved.Additional information received reported that corelab reported pipeline vantage fish mouthing (inward crimping of either end of the device) during study procedure performed on (b)(6) 2021.Additional information received reported that braid collapse of the pipeline vantage was observed at 6-month follow-up imaging on (b)(6) 2022.

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 braid collapse was determined during an independent mdt review of images.Further medical or surgical intervention was not performed.

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.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 that year 2 follow-up mra on (b)(6) 2023 showed raymond <(>&<)> roy class 1, with >75-100% parent artery stenosis (pas).

• Brand Name: PIPELINE VANTAGE WITH 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: 15534611
• MDR Text Key: 306633597
• Report Number: 2029214-2022-01654
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-450-14
• Device Catalogue Number: PED3-027-450-14
• Device Lot Number: B224652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• Date Device Manufactured: 06/22/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 64 KG