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

Model Number PED-500-35

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis of the pipeline flex embolization device (lot no.B031116) found that the pipeline flex pusher was protruding from within the marksman catheter hub for ~57.0 cm.No bends or kinks were found with the marksman catheter body.No damage was found with the marksman distal marker/tip.The pipeline flex braid, ptfe sleeves and tip coil were found partially deployed out from within the marksman distal tip.The pipeline flex pusher ptfe sleeves and tip coil were found in good condition.The pipeline flex embolization device was pushed out from within the marksman catheter, deploying the braid, with resistance.The distal hypotube with ptfe shrink tubing was found intact.The pipeline flex pusher was found detached at the distal hypotube weld (solder joint).The resheathing pad and marker were found detached from the distal core wire.The resheathing pad was found within the proximal end of the pipeline flex braid.The pipeline flex braid proximal end was found in good condition.The pipeline flex braid distal end was found damaged (frayed).Dried blood was noted within the pipeline flex braid.The detached pushwire was sent out for sem (scanning electron micrograp hic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end shows the presence of tin (sn).No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿r esistance¿ was confirmed.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.However, the cause for the resistance could not be determined.Solder joint separation can occur due to excessive force or inadequate solder/tinning.As the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.The event was reported in lieu of analysis results.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the microcatheter was kinked, and the pipeline stent could not be pushed.The pipeline was advanced completely through the catheter but didn't come out of the sheath.The physician was unable to continue delivery, and upon removal the catheter kink was found in the middle section of the catheter.Replacement products 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 angiography showed slow blood flow.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right ophthalmic artery with a max diameter of 14.7 mm and a 11.3 mm neck diameter.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet therapy (dapt) was not administered.Ancillary devices include a cook6 sheath, navien 5f 115 cm guidecatheter, marksman microcatheter, synchro2 guidewire.

Manufacturer Narrative

A4.Pt weight updated - 65kg 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: 11845066
• MDR Text Key: 251397963
• Report Number: 2029214-2021-00593
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016903
• UDI-Public: 00847536016903
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2023
• Device Model Number: PED-500-35
• Device Catalogue Number: PED-500-35
• Device Lot Number: B031116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 65