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

Model Number PED3-027-450-40

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problems Intracranial Hemorrhage (1891); Unspecified Nervous System Problem (4426); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2021

Event Type  Death  

Manufacturer Narrative

Initial information received did not indicate a reportable event.The event is reported conservatively at this time based on additional information received.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that there was twisting of the vantage device during the procedure.It was determined to be a temporary twisting and considered a technical issue rather than a device malfunction.The physician stated the device performed as expected and the procedure was completed successfully.Therefore, no further investigation was carried out by the site.Additional information was received and it was reported dual antiplatelet treatment (dapt) was administered.<(><<)> 5 days prior to index procedure, aspirin 300 mg loading and then 75 mg/daily for maintenance dose and prasugrel 60mg loading and 5 mg/daily maintenance dose.Aneurysm location left ica-c6.Aneurysm dimensions 32.5 x30 mm.Morphology fusiform.It was concluded that no device complaint to be reported as device was implanted successfully and physician did not see any device issue.No device damage ¿ devices were implanted successfully.Additional information received reporting that the event involved 2 pipeline vantage devices that were implanted for treatment of a left c6 ica fusiform aneurysm measuring 32.5mm with neck 30 mm.Incomplete neck coverage was noted.It was unknown if the event was related to a device deficiency or why 2 pipeline vantage stents were implanted.No patient symptoms were reported.Additional information received reported the second pipeline vantage was implanted to address incomplete neck coverage by the first pipeline vantage.It was not known at the time the information was received whether or not the incomplete coverage was due to any device malfunction.Neck coverage was achieved after implantation of the second pipeline vantage.

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 had an intracranial hemorrhage with death.The adverse event did result in hospitalization prior to the death.The adverse event resulted after post-procedure and was noted as probably related to the disease under study.The result was a new or worsening of the existing neurological deficits.The adverse event was possibly related to the antiplatelet medicine, possibly related to the device, and possibly related to the procedure.

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 corrected that the hospital end date was (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.

Event Description

Additional information received reported this case was considered a technical issue rather device malfunction.The physician also stated that the device performed as expected and procedure completed successfully.A construct with 2 vantage devices was made due to aneurysm size and morphology (giant fusiform aneurysm).

• Brand Name: PIPELINE VANTAGE EMOLIZATION DEVICE 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: 12594710
• MDR Text Key: 281103998
• Report Number: 2029214-2021-01259
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/22/2024
• Device Model Number: PED3-027-450-40
• Device Catalogue Number: PED3-027-450-40
• Device Lot Number: B165034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Date Device Manufactured: 02/22/2021
• 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): Hospitalization; Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 88 KG