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

Model Number PED2-500-20

Device Problems Positioning Failure (1158); Activation Failure (3270)

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Medtronic received a report regarding a pipeline failure to open in the distal stent region.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right internal carotid artery c2 with a max diameter of 10 mm and a 5 mm neck diameter.The landing zone was 4.7 mm distally and 5.0 mm proximally.The accessed vessel was the right middle cerebral artery with a diameter of 3.5 mm.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy was administered.The pru level is unknown.The postoperative findings related to blood flow imagining were good.It was reported that the tip deployment was initiated at the distal end (m1), the sleeve removal was performed once, and it was moved to the placement site because the tip tended to extend in front of the tip.However, previously, only the tip continued to have poor deployment.The sleeve was removed in order to obtain the tip deployment at m1 again and a system push was performed, but it was not deployed, so it was removed.It was reported that the pipeline failed to deploy in the distal stent region.The pipeline was not positioned in a bend.The pipeline had been deployed less than 50% when it failed to open.The pipeline had been resheathed two or fewer times.Another operation was not performed such as using another device to deploy the stent.The stent was removed from the patient.The pipeline was resheathed and retrieved with the microcatheter.It was reported there was also poor deployment positioning.Multiple pipelines were not being used when migration occurred.There was no resistance during delivery or stent placement observed.The stent was not placed at the target site.There were no protective additional treatments performed.It was not possible to place the stent in the landing zone.There was no jumping in the device during delivery.The implanted pipeline did cover more that 3mm of both ends of the aneurysm neck (total 6mm or more).The side branch, ophthalmic artery, was covered with pipeline.The catheter tip did not migrate during stent expansion.It was reported the phenom catheter was used to induce the pipeline of the defective product.The catheter was flushed as indicated in the instructions for use (ifu).The device was prepared as indicated in the package insert.The pipeline was not used for an indication that is not approved off-label.No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a venture guidewire.

Manufacturer Narrative

Healthcare professional information not available due to privacy laws.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.

Manufacturer Narrative

H3: product analysis #705341768:equipment used: vis (m-78210), 203cm ruler (m-83361) document used: dwgsfg15xxx-yyyy-zz rev.F as found condition (condition of returned device): (b)(4) pipeline flex embolization device and a phenom-27 catheter were returned for analysis within a shipping box; within an opened pipeline flex embolization device outer carton and within a resealable biohazard bag.Visual inspection/damage location details: the inner diameter (id) of the phenom-27 microcatheter was found to be 0.027¿ per ifu (instructions for use).Per pipeline flex embolization device instructions for use (ifu): ¿the pipeline flex embolization device is designed to be delivered through a compatible micro catheter of 0.027¿ inside diameter.Therefore, the phenom-27 micro catheter was found to be compatible for use with the pipeline flex embolization device.The pipeline flex was returned within the phenom catheter and found to be extending ~45.1cm from hub and ~2.9cm from distal tip.The pipeline flex embolization device was then pushed out from phenom for further evaluation; however, the pipeline was unable to be removed fully.(pli-10) no bends or kinks were found with the pipeline pushwire.The hypotube and ptfe were found to be intact and with blood residue.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves appeared to be in good condition.The tip coil was found to be damaged.The proximal braid end was found to be opened and frayed.The distal braid end was found to be opened and frayed.(pli-20) no device malfunction was reported with the phenom-27 catheter.The phenom-27 catheter total length was measured to be ~(b)(4).The phenom useable length was measured to be ~151.0cm which is within specification.Upon visual inspection, no damages were found with the phenom hub.The catheter body was found to be kinked at ~2.2cm from distal tip.No damages were found with the marker band or the distal tip.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was unable to be confirmed as pipeline flex braid ends were found to be open.Possible cause for ¿failure to open distal¿ is the result of damaged braid or braid was overstretched during delivery.Based on the device analysis and reported information, the customer¿s report of ¿difficult placement/positioning¿ was unable to be confirmed and the root cause could not be determined.Possible causes for ¿difficult placement/positioning¿, are resistance, braid damaged, or microcatheter tip not correctly places.(reyesr32 2023-01-13) 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: 15905205
• MDR Text Key: 307777937
• Report Number: 2029214-2022-02034
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: B405831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2022
• 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