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

Model Number PED-450-12

Device Problem Activation Failure (3270)

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

Event Date 09/21/2020

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 physician deployed the distal end of the pipeline, but it did not open correctly.The pipeline looked like a tulip, and was recaptured twice but still didn't look right.It was noted thepipeline was not positioned in a bend, less than 50% was opened, and no additional steps were taken in an attempt to open the device.The catheter and pipeline were removed together, and 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 good results.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the posterior communicating (pcom) artery.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 112.

Manufacturer Narrative

Product analysis #(b)(4): equipment used: vis (m-78210), 203cm ruler (m-83361) the pipeline flex embolization device and phenom 27 catheter were returned for analysis within a shipping box; within a tyvek bio-pouch; within primary and sealed plastic bio-pouches and within a re-sealable plastic bio-pouch.The pipeline flex embolization device was returned within the phenom 27 catheter.The pipeline flex pusher was found protruding from within the phenom 27 catheter hub for ~45.0cm.No damage was found with the phenom 27 catheter hub.No bends or kinks were found with the phenom 27 catheter body.No damage was found with the phenom 27 distal marker/tip.The pipeline flex braid, ptfe sleeves and tip coil were found protruding from within the phenom 27 distal tip.The ptfe sleeves and tip coil were found to be in good condition.The phenom 27 catheter total length was measured to be ~156.5cm and the usable length was measured to be ~ 149.8cm which is within specification.The pipeline flex embolization device could not be pushed or pulled out from within the phenom 27 catheter due to resistance.Therefore, the phenom 27 c atheter was dissected (cut) and the pipeline flex embolization device was removed.The pipeline flex distal hypotube and ptfe shrink tubing were found intact.The pipeline flex pusher was found detached at the distal hypotube weld (solder joint).The pipeline flex distal segment was found stuck within the phenom 27 catheter at ~3.5cm from the distal tip.The resheathing pad/marker were found in good condition.The pipeline flex braid ends were found fully open.The pipeline flex braid distal end was found damaged (frayed).Dried blood was present on the pipeline flex braid.The detached pushwire was sent out for sem (scanning electron micrographic) / 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 ¿failure/incomplete open¿ could not be confirmed, as the device has been fully deployed and re-sheathed.Possible causes for failure to open are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents, or inappropriate anatomy.It is possible the damage found with the braid and the patient¿s ¿moderate¿ vessel tortuosity contributed to the event; however, the root cause could not be determ ined.Regarding the solder joint separation issue, 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.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to specification that lead to the resistance and detachment issues.Furthermore, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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: 10584383
• MDR Text Key: 208573023
• Report Number: 2029214-2020-00969
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016354
• UDI-Public: 00847536016354
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2021
• Device Model Number: PED-450-12
• Device Catalogue Number: PED-450-12
• Device Lot Number: A690239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1