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

Model Number PED2-500-14

Device Problems Material Deformation (2976); Activation Failure (3270)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the distal part of the pipeline failed to open and appeared to be damaged.The patient was undergoing treatment for a ruptured, saccular aneurysm located in the ica.The aneurysm had previously undergone coiling.The landing zone was 3.9mm distal and 4.45mm proximal.The patient's vessel tortuosity was severe.The patient was not on dual antiplatelet treatment.It was reported that the distal part of the pipeline was placed in a bend when it failed to open, and less than 50% had been deployed at the time.The pipeline had been resheathed two or less times.No additional attempts were made to open the device.The pipeline was removed and replaced. angiographic results post procedure showed a good final result with the second device. the patient did not experience any injury or complications.It was noted that the devices were not prepared according to the instructions for use (ifu); the device was manually back flushed very aggressively and tightened down very hard on the device making it hard to push the fluid to hydrate.The manufacturer representative believed may have impacted the device and damaged distal end.Ancillary devices include an infinity sheath, phenom plus guide catheter, and phenom 27 microcatheter.

Manufacturer Narrative

H3: the pipeline flex shield braid was returned for analysis.There was no pushwire returned with the braid.The distal and proximal ends of the braid were fully opened and frayed.No other anomalies were observed.Based on the returned device, the pipeline flex shield were not confirmed to have failure to open at the distal end as the distal and proximal ends of the braid were fully opened and frayed.The damage to the braid on the ends is likely the results of the physician re-sheathing the device more than recommended two times.It is likely that the severe vessel tortuosity may have contributed to the failure to open issue.There was no non-conformance to specifications identified that led to the failure to open issue.Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex shield embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex shield embolization device has successfully expanded, deploy the remainder of pipeline flex shield embolization device by pushing the delivery wire and/or unsheathing the pipeline flex shield embolization device.Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex shield embolization device.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex shield embolization device.Re-sheathing the pipeline flex shield embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Do not use in patients in whom the angio graphy demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿.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.

• 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: 12105035
• MDR Text Key: 259718049
• Report Number: 2029214-2021-00804
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284695
• UDI-Public: 00763000284695
• 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,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2024
• Device Model Number: PED2-500-14
• Device Catalogue Number: PED2-500-14
• Device Lot Number: B179373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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 Sex: Female