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

Model Number PED-450-35

Device Problem Activation Failure (3270)

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

Event Date 09/06/2020

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 segment of the pipeline failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the cavernous sinus with a max diameter of 23.29mm and a 7.89mm neck diameter.It was noted the patient's vessel tortuosity was moderate.It was unknown if dual antiplatelet therapy (dapt) was administered.It was reported that after the pipeline flex reached the predetermined position with the marksman microcrater, the pipeline could not be opened during the process of retracting the microcatheter.The instructions in the operation guide were followed to deploy and wait more than ten minutes, then the pipeline was retrieved and deployed two times.The distal end of the pipeline still could not open.It was stated the device was not positioned in a bend, more than 50% had been deployed when it failed to open, resheathing was done more than 2 times, and no additional steps or devices were used to try and open the pipeline.The marksman and pipeline were then removed together from the patient.Replacement devices were used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results showed satisfactory blood flow guidance.Ancillary devices include a ev3 marksman 150, ev3 navien 5f 115.

Manufacturer Narrative

The pipeline flex pushwire was returned outside the marksman catheter.The pipeline flex braid was stuck inside the marksman catheter proximal end and hub.For further examination, catheter was cut to remove pipeline flex braid.When compared to the drawings 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.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip, marker and body were examined; and no damages were found.No flash or voids molded were observed in the hub.The catheter was flushed with water and water exited out from 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, lumen and tip with no issues.No other anomalies were observed.Based on the analysis findings, the pipeline flex was not confirmed to have failure to open at the distal end.However, the root cause and the cause for damage could not be determined.Possible contributing factor of failure to open includes patient tortuous anatomy.It was reported, the patient's vessel tortuosity was moderate there was no non-conformance to specifications identified that led to the failure to open issue.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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10504931
• MDR Text Key: 206170618
• Report Number: 2029214-2020-00905
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016569
• UDI-Public: 00847536016569
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2022
• Device Model Number: PED-450-35
• Device Catalogue Number: PED-450-35
• Device Lot Number: A887321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR