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 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex embolization device and marksman catheter were returned for analysis within a shipping box and within a plastic bio-pouch.Visual inspection/damage location details: the pipeline flex embolization device was returned within the marksman catheter.The pipeline flex pusher was found extending from within the marksman catheter hub for ~46.0cm.The marksman catheter body was found accordioned from ~29.5cm to ~27.0cm from the distal tip.The pipeline flex tip coil was found extending out from within the marksman distal tip.No damages were found with the marksman distal tip.The pipeline flex embolization device could not be removed from within the marksman catheter as it was found stuck.The marksman catheter was dissected (cut) and the pipeline flex embolization device was removed.No bends or kinks were found with the pipeline flex pusher.The pipeline flex pusher was found detached at the distal hypotube weld (solder joint).The proximal end of the pipeline flex braid was found in good condition; however, the distal end was found damaged (frayed).No damage was found with the pusher sleeves.The pusher tip coil was found bent.Testing/analysis: the detached pusher was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pusher end shows the presence of tin (sn).Conclusion: based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿ report was confirmed.From the damages seen with the marksman catheter (accordioning) it appears force may have been used.Regarding the solder joint separation issue, this event is similar to events that had already been investigated, and another investigation is not necessary (see (b)(4) regarding the pipeline flex pushwire separation issue).Based on the formal investigation conducted, solder joint separation can occur due to excessive force or inadequate solder/tinning.As the analysis showed the 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 (b)(4) was performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to a specification that led 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.

Event Description

Medtronic received report that the catheter reached the distal tip of the aneurysm and they were ready to deploy the pipeline.After repeated attempts, the stent could not be pushed out of the catheter and was replaced with a shapeable microcatheter, phenom27.The ped-4.75-30 was implanted to bridge the ped4.75-35 and the effect was good.The operation was successfully completed.The stent was stuck at the distal end of the catheter.The catheter was flushed continuously with heparinized saline.The physician released the load in the system in an attempt to resolve the issue however this did not resolve the issue.The catheter was not damaged nor was the pushwire damaged.The devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.There were no patient symptoms or complications associated with the event.The patient was undergoing surgery for treatment of a amorphous, unruptured aneurysm with a max diameter of 18mm and a 8mm neck diameter.It was noted the patient's vessel tortuosity was normal.The angiographic post procedure showed contrast agent retention was obvious, the dense net stent stuck to the wall well.

• 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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14210916
• MDR Text Key: 299275370
• Report Number: 2029214-2022-00712
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016903
• UDI-Public: 00847536016903
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-500-35
• Device Catalogue Number: PED-500-35
• Device Lot Number: B222602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Date Manufacturer Received: 03/28/2022
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male