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

Model Number PED-425-14

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report of pipeline pushwire separation at the distal section.It was reported that the pipeline deployed as expected, however, upon recapturing the delivery wire broke off within the phenom microcatheter near the hub of the phenom.The patient underwent treatment of a left, unruptured, saccular pcom aneurysm.The max diameter was 6 mm and the neck was 5 mm.The distal landing zone was 3.5 mm and the proximal was 4.2 mm.The vessel anatomy was moderate in tortuosity.No patient injury was reported to have occurred.The devices were prepared and used per the instructions for use(ifu).Ancillary devices: cerebase da guide sheath, navien.058 (b022496), phenom 27 fg15160-0615-1s fe20-033, aristotle a18-200-002 (lot 502009).

Manufacturer Narrative

H3: equipment used: video inspection system (m-77148), ruler (m-83360), camera the pipeline flex pusher (model: ped-425-14 lot: a856751) and microcatheter were returned for evaluation within a shipping box; within a sealed plastic biohazard pouch; within a second resealable plastic biohazard pouch and without a dispenser coil or introducer sheath.The braid was not returned for analysis.The devices were decontaminated as per manufacturer protocol.The pusher hypotube was found broken near the distal end of the hypotube with the ptfe shrink tubing damaged at that same location.No stretching was found with the hypotube.The distal broken segment was not returned for analysis.The broken end of the hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.Sem/eds summary: ¿the fracture surfaces exhibit corrosion damage.Some areas were covered with residues.The fracture features (dimples) observed indicate an overload type failure mechanism.¿ no flash or voids molded were observed in the catheter hub.The catheter total length was measured to be ~168.9cm, the usable length was measured to be ~162.1cm and the distal single coil length was measured to be 14.5cm which is within specification per drawing (reference) = 166.5cm, usable length = 160cm ± 5cm; distal single coil length = 15cm ±2cm).The catheter body was found kinked at ~39.8cm from the proximal end.No damages or irregularities were found with the distal tip and marker band.The inner diameter of the catheter was measured via pin gauge to be 0.0275¿ (proximal) and 0.0270¿ (distal) which is within specification and compatible for use with the pipeline flex device.An in-house 0.026¿ mandrel was then used for resistance testing.The mandrel was inserted through the catheter hub, through the catheter body and exited the catheter tip with no issues and no resistance encountered.No other anomalies were found.Based on the analysis findings, the customer report of ¿catheter resistance¿ could not be confirmed as no resistance was found with the catheter during mandrel testing.The customer report of ¿pushwire break/separation¿ was confirmed.It is possible the customer used high force when retracting the pusher and advancing the catheter against resistance causing the hypotube to break.Customer reported resistance within retracting the pipeline flex pusher.The sem testing results confirm an overload type failure.Per manufacturer instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ possible contributors towards failure are patient vessel tortuosity, catheter damage or user re-sheaths more than two times.Customer reported patient vessel tortuosity as moderate.The review of lot history records shows that the finished pipeline flex 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: 10182308
• MDR Text Key: 209623177
• Report Number: 2029214-2020-00581
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016118
• UDI-Public: 00847536016118
• 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: 08/03/2020

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: 06/28/2022
• Device Model Number: PED-425-14
• Device Catalogue Number: PED-425-14
• Device Lot Number: A856751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/26/2020
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 54