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

Model Number PED-425-16

Device Problem Break (1069)

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

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

As the device was received in a condition was contradictory to the complaint description.The pipeline flex device pushwire found broken.This condition was not reported at time of the event.The pipeline flex pushwire was returned outside the medtronic catheter.The pushwire was found to be separated/broken proximal to the dps sleeves.The tip coil and dps sleeves were not returned for analysis and the reason was not provided.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The hypotube was found to be stretched.No bend or kink were observed on the pushwire.The catheter was then tested by running an in-house mandrel through catheter tip and hub to remove the braid.The mandrel successfully passed through the catheter hub and tip without any resistance and the braid pushed out from the catheter with no issues.The distal and proximal ends of the pipeline flex braid were found opened and moderately frayed.The pushwire broken segment sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analysis.Per the sem result features observed indicate the wire failed via torsional overload failure mechanism.From the damages seen on the catheter body (kinking), pipeline flex braid (fraying) and hypotube (stretching); it is likely high force used during the delivery.It is likely that the patient tortuous anatomy may have contributed to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that pipeline flex stuck (locked up) in catheter or resistance in medtronic catheter.It was reported that heavy resistance in insertions of pipeline into the catheter immediately felt heavy resistance.The catheter flushed continuously with heparanized saline.Reported device and any accessory devices were prepared as indicated in the ifu.Removed and replaced the both devices.Once devices replaced new pipeline and medtroinc worked without issue.The patient was being treated for a 5mm aneurysm of the left internal carotid artery.The vessel tortuosity was moderate, there were no patient symptoms, complications, or involvement.Evaluation of the returned device found that the pipeline flex device pushwire found broken.

Manufacturer Narrative

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: 10350834
• MDR Text Key: 202378367
• Report Number: 2029214-2020-00759
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016149
• UDI-Public: 00847536016149
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2021
• Device Model Number: PED-425-16
• Device Catalogue Number: PED-425-16
• Device Lot Number: A704308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 70