MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-450-25

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a pipeline device pushwire that broke during a procedure.The patient was being treated for and unruptured saccular aneurysm.Vessel tortuosity was moderate.It was reported that the device and accessories were prepared as indicated in the manufacturer instructions for use.Though not sever, the patient's anatomy was still rather tortuous and the physician mentioned this multiple times during the procedure.It was noted that the surgical system set-up was not ideal as the support catheter was too proximal to the aneurysm.The physician started to deploy the pipeline to the tip of the catheter and had to you strong force during the deployment.During this process, the physician noted that the pipeline pushwire broke and immediately removed the entire system from the patient.No product was left behind.The surgeon then replaced the pipeline and selected a different catheter model and was able to complete the procedure successfully.The patient did not sustain any harm or injury.

Manufacturer Narrative

Device available for evaluation - additional information date mfr rec ¿ additional information type of follow up - device evaluation device evaluated by manufacturer- codes updated only the pushwire was returned for evaluation.There was no pipeline flex braid returned with the pushwire.The pushwire appeared to be separated from the proximal end.The separation location was where the corewire met the hypotube.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bend was observed on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.The broken end will be sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analysis.Based on the returned device, the pipeline flex was confirmed to have pushwire separation issue.Per the sem/eds results: "the predominant fracture features observed are dimple features consistent with overload type failure." it is possible that the patient tortuous anatomy may have contributed to the strong resistance during delivery; subsequently causing the pushwire to separate.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 EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10022106
• MDR Text Key: 196609150
• Report Number: 2029214-2020-00429
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016507
• UDI-Public: 00847536016507
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: A823556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1