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

Model Number PED2-500-30

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Unintended Movement (3026); Migration (4003)

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

Event Date 11/18/2022

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 a report regarding pipeline (lot # b376652)  difficult placement/positioning and pipeline (lot # b375979 and lot# unknown) failure to open distally.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm located in the cavernous with a max diameter of 2.5mm and a 15mm neck diameter.The landing zone was 4mm distally and 5mm proximally.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet treatment (dapt) was administered.The pru level was 100.The angiographic result post procedure showed the pipeline was not covering the proximal neck, but still had good flow.No patient symptoms or further complications were reported as a result of this event.   it was reported that two devices were pulled out as distal end would not open as desired.The third device was implanted but end result was it pushed into proximal aneurysm and could not re-access or snare out.Patient is stable and good flow thru the vessel at this time.It was reported for pipeline (lot # b376652) that while attempting to balloon pipeline - proximal end of pipeline foreshortened about 10 mm and pushed into proximal end of aneurysm.Which could not be re-accessed to fix.It was reported the pipeline was difficult to place and position.The pipeline was not used for an indication that is off-label.The pipeline and any accessory devices were prepared as indicated in the instructions for use (ifu).Multiple pipeline devices were not being used when movement occurred.There was moderate friction or difficulty during delivery or positioning.The pipeline was implanted at the intended location.The pipeline missed the landing zone.To remove or secure the pipeline it was attempted to balloon with sceptor and pushed proximal end forward, it could not re-access or snare out.The device did not jump during deployment.The pipeline was placed at least 3mm past the aneurysm neck on each side.The opthal branch was covered by the pipeline.The tip of the catheter did not move during deployment; migration after deployment.The cause of the migration was the attempt to balloon and push implant device forward.The pipeline was placed in the intended location.Full wall apposition was not achieved.Ballooning was required for tapering or to ensure wall apposition.It was reported for pipeline (lot # b375979 and lot # unknown) that it failed to open distally.The pipeline was positioned in a bend in the distal segment.It was not specified whether the pipeline was stuck in the capture coil.The pipeline had been deployed less than 50% when it failed to open.The pipeline was resheathed more than two times.There were no additional steps or other devices required to open the pipeline.The pipeline was removed from the patient.The pipeline was resheathed and removed with the microcatheter.  ancillary devices include a navien 058 guide catheter and phenom 027 microcatheter.

• 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: 15964340
• MDR Text Key: 307817394
• Report Number: 2029214-2022-02107
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284749
• UDI-Public: 00763000284749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: B376652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Date Device Manufactured: 04/28/2022
• 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: 81 YR
• Patient Sex: Female