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 Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved in the event has not been returned for evaluation; therefore, the event cause could not be determined.Correspondence has been sent to the customer for the device return and additional information.Once this is received, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the medtronic flow diverter¿s distal end did not open despite several attempts to open it.It was also trapped inside the microcatheter.The flow diverter and microcatheter were exchanged for a new one to complete the procedure.The patient was undergoing embolization treatment of an unruptured saccular aneurysm measuring 12mm x 7mm located in the left carotid siphon.The distal and proximal landing zone was 3.9mm x 5.1mm.The vasculature was severe in tortuosity.

Manufacturer Narrative

H3: product analysis #703467968:¿ equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ,drawing(s) referenced: fg-15xxx-yyyy-zz rev.B , as found condition: the pipeline flex shield embolization device and phenom 27 catheter were returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex shield pusher was returned outside the phenome27 catheter.There was no pipeline flex shield braid returned for analysis.Therefore, any contributing factors could not be assessed.Damage location details: no bend was observed on the pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No defects were found with the proximal bumper, re-sheathing pad, re-sheathing marker, distal marker, and tip coil.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No flash or voids molded were observed in the hub.The catheter body was found to be kinked at ~26.7cm from distal end.In addition, the catheter body was found to be flattened at ~7.4cm from distal tip.The distal tip was found to be accordioned.No other anomalies were observed.Testing/analysis: the total and usable lengths of phenom 27 catheter was measured to be within specification.The catheter was flushed with water and water exited out of the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged locations.Conclusion: based on the analysis findings, the pipeline flex shield was not confirmed to have failure to open at the distal end as the pipeline flex shield braid was not returned.Possible causes of failure to open includes patient tortuous anatomy and damage to the braid.It was noted the pipeline was resheathed more than 2 times.However, the marksman catheter was confirmed to have resistance as the marksman catheter was found to be damaged.From the damages seen on the catheter body (accordioning/kinking/flattening; it appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex shield through the phenom 27 catheter against resistance.It is likely the severe vessel tortuosity may have contributed to the reported issues.(nikkhs2 2023-04-12) 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: 9358898
• MDR Text Key: 179546805
• Report Number: 2029214-2019-01155
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: A620904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2018
• 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