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

Model Number PED2-450-20

Device Problems Break (1069); Positioning Failure (1158); Component or Accessory Incompatibility (2897); Material Deformation (2976); Unintended Movement (3026)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

Medtronic received information that a ped2 pipeline broke off and deployed and remains implanted.The pipeline was used for the treatment of an unruptured cerebral aneurysm.Spindle-shaped vascular irregularity was observed near the distal portion of the placement site, and the placement was in the curved portion of the c3 section.The pipeline deflected on the convexity of this vascular irregularity midway through the deployment, and the deflected pipeline fit in the same area.Moreover, it was placed in a curved area, and it is likely that tension was applied to the device in the proximal concavity of the same area as it was deployed through a wire push.The device was unable to withstand the tension and broke off, entering the lumen of the pipeline deployed at the spindle-shaped irregularity.The settings of the angiography equipment (siemens) were not correct, making it difficult to see the device, which was revealed by performing cone-beam imaging to check the degree of crimping with the blood vessel after placement.There is no means to resolve the problem, and it remains inside the patient.In postoperative findings the pipeline was also covering the distal neck, so an eclipse sign was observed in the aneurysm.There were no findings of blood flow stagnation in the mother blood vessel.The patient was being treated for an unruptured, saccuar aneurysm in the right internal carotid artery c3.The max diameter was 11mm and the neck diameter was 4mm.The distal landing zone was 4.0mm and the proximal landing zone was 4.71mm.Vessel tortuosity was normal.No health damage was reported.

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.

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

New information received.No additional surgery or intervention was needed and the patient was discharged from the hospital without any problems.The images were rejected to be provided due to individual privacy.The damage is in the device part of the pipeline.One pipeline was placed.There was no particular resistance, but the visibility of the tip during deployment was poor (due to improper setting of angiography).The pipeline was implanted at the intended location.The device did not jump during deployment.It was unable to confirm if the tip of the catheter moved during deployment since the visibility was poor.

• 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: 16152574
• MDR Text Key: 308847444
• Report Number: 2029214-2023-00058
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• 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: 74 YR
• Patient Sex: Female