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

Model Number PED3-027-500-14

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

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

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

See manufacturer report # 2029214-2022-00232 for the other pipeline involved in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that a pipelines failed to open proximally, and a replacement pipeline failed to open distally.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the paraophthalmic artery.The max diameter was 6mm, and the neck diameter was 5mm.The patient's vessel tortuosity was normal.The landing zone was 3.3mm distal and 5.1mm proximal. dual antiplatelet treatment was administered.It was reported that navigation was straight forward, and the device was navigated to the desired location.The patient's anatomy was normal.The distal end of the first pipeline was flared proximal to the posterior communicating artery (pcom).The device opened around the cavernous bend with loading and unloading the entire system.The stent was long and the physician claimed there was a twist as the stent came into the cervical ica.Repeated attempts to untwist this section was unsuccessful, and the device was replaced.A shorter pipeline was used, but this time the distal end of the stent did not fully appose while the mid-section was well apposed.The physician attempted to load and unload the entire system, which caused the distal end of the device to fall back and miss the landing zone.The pipeline jumped, and had been placed at least 3mm past the aneurysm neck on each side.No side branches were covered, and the tip of the catheter was moved during deployment.The second pipeline was also removed. the case was abandoned, but patient did not experience any injury or complications. the proximal and distal part of the first pipeline was positioned in a bend, and the distal part of the second pipeline was positioned in a bend when they failed to open.More than 50% had been deployed when they failed to open.The pipelines were resheathed 2 or less times, and no other steps were taken to open the device.There had been no friction or difficulty during delivery or positioning. the devices were prepared according to the instructions for use (ifu).Ancillary devices include a 7f short sheath, rist 079 guide catheter, sofia 5f guide catheter, and a phenom 27 microcatheter.

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 cause of the event had not been determined.The physician believed it was the device that was at fault.They cited normal anatomy, therefore tortuosity should not have been an issue.The first stent opened well distally, but there appeared to be torsion mid proximal segment.The second stent was much shorter.The distal end did not open and fell back too far, but proximal end was fine.

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 the second pipeline was discarded and won't be returned for analysis.

• 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: 13550917
• MDR Text Key: 294666804
• Report Number: 2029214-2022-00233
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: PED3-027-500-14
• Device Catalogue Number: PED3-027-500-14
• Device Lot Number: B229656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 02/18/2022; 03/08/2022
• Supplement Dates FDA Received: 02/28/2022; 03/20/2022
• Date Device Manufactured: 07/02/2021
• 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