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

Model Number PED3-021-275-16

Device Problems Unintended Movement (3026); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2023

Event Type  malfunction  

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

Medtronic received information that a ped3 pipeline failed to open and migrated during deployment.While deploying ped3 vantage 2.75x16, the distal and mid segment were well apposed, but the inner curve of proximal end wasn't.Before managing this, plan was to capture tip coil in microcatheter, so phenom was taken over the wire during which the entire device from proximal end got pushed/crumpled and landed just above the neck of aneurysm.Second device was hence chosen.Ped3 vantage 2.75x14 was deployed by overlapping with 1st fd and finally good wall apposition was achieved at proximal end too.Distal vessels and good crossflow was also observed.The cause of the migration as it got pushed into distal vessel while taking phenom up to capture tip coil of device.The pipeline was implanted at the intended location.Full wall apposition was not achieved.Ballooning was not required to ensure wall apposition.The left anterior cerebral artery (aca) side branch was covered by the pipeline.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for a ruptured, blister aneurysm in the left supracloniod internal coratid artery (ica).The max diameter was 0.7mm and the neck diameter was 0.8mm.The distal landing zone was 2.3mm and the proximal landing zone was 2.5mm.Vessel tortuosity was severe.No patient injury or symptoms were reported.  ancillary devices: neuronmax ox sheath, navien 5f guide catheter, phenom 21 microcatheter, synchro 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 received that there was friction or difficulty during delivery or positioning.The device jumped during deployment.The tip of the catheter was not moved during deployment.The pipeline had not been placed in a vessel bend when it failed to open.

• 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: 16753520
• MDR Text Key: 313496390
• Report Number: 2029214-2023-00652
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-021-275-16
• Device Catalogue Number: PED3-021-275-16
• Device Lot Number: B458076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Date Device Manufactured: 10/06/2022
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 63 KG