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

Model Number PED2-500-30

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported physician information cannot be provided due to the restriction by the privacy regulation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the devices were prepared and hydrated per the instructions for use (ifu).However, the pipeline experienced resistance in the middle section of the phenom catheter.Once the pipeline was positioned, it was found the distal tip of the pipeline failed to open.It was noted the distal part of the stent was positioned in a bend, less than 50% had been deployed, resheathing was performed more than three times, and no additional steps or devices were used in an attempt to open the stent.There was little impact to the catheter operation, so the phenom and pipeline were removed from the patient together.Replacement products were then used to complete the procedure.There was no injury to the patient as a result of the event.Post-procedure angiography showed slowed blood flow.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm of the left internal carotid artery c2-c3 segment with a max diameter of 6-7 mm and a 5 mm neck diameter.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet therapy (dapt) was administered.Ancillary devices include a 8f roadmaster 80cm, chikai14 200.

Manufacturer Narrative

H3: the pipeline flex embolization device and phenom 27 catheter were returned for analysis.The pipeline flex pusher was found stretched and detached at the hypotube proximal to the wire weld.The pipeline flex distal core wire was found broken at ~39mm from its proximal end.The phenom 27 catheter was examined.The phenom 27 catheter total length was measured to be ~158.4cm and the useable length was measured to be ~151.8cm which is within specification (specification: 150cm ± 5cm).No damage was found with the phenom 27 catheter hub.The phenom 27 catheter body was found kinked at ~11.1cm, 8.8cm, and 7.9cm from the distal tip.The phenom 27 distal tip was found kinked and flattened.An in-house 0.026¿ mandrel was inserted into the phenom 27 catheter but met resistance at ~11.1cm from the distal tip.The phenom 27 catheter was dissected (cut) and the pipeline flex braid and tip coil were removed.The pipeline flex braid ends were found opened, but damaged (frayed).The pipeline flex distal core wire was found broken proximal to the ptfe sleeves.The distal core 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).The broken distal core wire end exhibits features indicating failure due to snipping tools.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ was confirmed.It is possible the damage (kinking) found with the returned phenom 27 catheter contributed to the event.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.It is likely the braid became damaged, and the pusher became stretched, detached and broken due to the reported resistance.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 perform ed 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.The investigation determined that this event is similar to events that had already been investigated, and another investigation is not necessary.Regarding the customer¿s report of ¿failure/incomplete open¿ the issue 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 an atomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents, or inappropriate anatomy.In this event, it is possible the damage found with the braid (fraying), the patient¿s ¿severe¿ vessel tortuosity, and the deployment of the braid in a vessel bend contributed to the event.However, the root cause could not be determined.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 W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10675944
• MDR Text Key: 211468655
• Report Number: 2029214-2020-01027
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: A912444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR