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

Model Number PED-425-35

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/21/2021

Event Type  malfunction  

Event Description

Medtronic received a report that the pipeline became stuck in the distal end of the phenom catheter during delivery.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the cavernous sinus artery.The max diameter was 4.67mm*4.32mm.The neck diameter was 4.87mm.The patient's vessel tortuosity was normal.The landing zone was 3.56mm distal and 4.13mm proximal.The access vessel was the femoral artery, which was 5mm in diameter.It was reported that the catheter was flushed continuously with heparinized saline.The physician released the load/slack in the system, but this did not resolve the issue.It was noted that the distal section of the catheter was damaged.There was no damage to the pushwire. the devices were replaced, and the patient did not experience any injury or complications. angiographic results post procedure were normal. the devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include an 8f sheath, 5f125 medtronic guide catheter, and synchro14 guidewire.

Manufacturer Narrative

The pipeline flex embolization device and phenom 27 catheter were returned for analysis.The pipeline flex pusher distal hypotube was found stretched with the shrink tubing pulled back from the proximal bumper.The proximal bumper and resheathing pad were found in good condition.However, the pusher distal core wire was found broken.The phenom 27 catheter was examined.The phenom 27 catheter hub, catheter body, and distal tip were in good condition.The phenom 27 catheter was dissected (cut), and the pipeline flex braid, ptfe sleeves, and tip coil were removed from within the distal catheter end.The pipeline flex braid ends were found open but damaged (frayed).It was observed that the pipeline flex distal core wire broke at the ptfe sleeves.The ptfe sleeves and tip coil were found damaged.The broken core wire was sent out for sem (scanning electron micrographic) analysis.Per the analysis report, the wire failed via torsional overload.Based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿ report was confirmed; however, the customer¿s ¿catheter kink/damage¿ report could not be confirmed.The investigation determined that the resistance event was similar to those already investigated, and another investigation is not necessary.Based on the investigation conducted, resistance can occur during the device's tracking, deployment, and re-sheathing in distal and tortuous anatomies.However, the patient¿s vessel tortuosity was ¿normal.¿ in addition, it was reported that a continuous flush was maintained, and no damages were found with the returned phenom 27 catheter that would have contributed to the reported resistance issue.Therefore, the cause for the resistance could not be determined.Regarding the pusher separation, this event is similar to events that had already been investigated, and another investigation is not necessary.Based on the formal investigation, separation can occur due to certain use conditions such as excessive force or patient vessel tortuosity.From the damages seen on the pipeline flex pusher (stretching), it appears excessive force may have been used.It is also likely that the reported resistance contributed to the separation.If information is provided in the future, a supplemental report will be issued.

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: 12456323
• MDR Text Key: 281326578
• Report Number: 2029214-2021-01155
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016293
• UDI-Public: 00847536016293
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: PED-425-35
• Device Catalogue Number: PED-425-35
• Device Lot Number: B168888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 76