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

Model Number	PED-350-30
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is reported at this time based on analysis results which indicated a reportable event.Product analysis: equipment used: vis (m-81805), 203cm ruler (m-83360) as found condition: the pipeline flex embolization device, phenom 27 catheter, and navien catheter were returned for analysis within a shipping box, within a plastic bio-pouch, and within an opened pipeline flex inner pouch (b191457).An opened phenom 27 inner pouch (se21-005) and an opened navien inner pouch (b251412) were also returned within the plastic bio-pouch.Visual inspection/damage location details: the pipeline flex embolization device was found stuck within the phenom 27 catheter.The pipeline flex pusher was found extending out from within the phenom 27 catheter hub for ~48.0cm.The phenom 27 catheter distal marker was found crushed.The phenom 27 catheter was dissected (cut) to remove the stuck pipeline flex embolization device.No bends or kinks were found with the pipeline flex pusher.No stretching or elongation was found with the pipeline flex pusher.The pusher was found detached at the distal hypotube weld (solder joint).The pipeline flex braid proximal end was found damaged (frayed).The pipeline flex braid distal end was found not open.Dried blood was noted within the braid distal end.The pipeline flex pusher sleeves were found in good condition.Dried blood was noted on the pipeline flex pusher tip coil.The tip coil was found to have detached and was loose on the distal core wire.Testing/analysis: the detached pusher was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental and failure 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.Damages found with the pipeline flex embolization device (pusher detached, braid damage) can occur if the device is advanced/retrieved against resistance.Resistance can occur during tracking, deployment, and re-sheathing of the device in distal and tortuous anatomies.In addition, resistance can occur due to use of an incompatible catheter, catheter damage, user does not maintain continuous flush, or users pulls back on/torques wire while advancing the pipeline flex in the catheter.The patient¿s vessel tortuosity was ¿moderate¿, the phenom 27 catheter is compatible for use with the pipeline flex embolization device, and a continuous flush was used.In this event, it is likely the damage found with the phenom 27 distal tip (crushed marker) contributed to the reported resistance.However, the cause for the damage could not be determined.Regarding the solder joint separation issue, separation can occur due to excessive force or inadequate solder /tinning.The analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.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 led to the detachment issue.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 or Problem Description
Medtronic received a report that implant was attempted repeatedly, however, the dense mesh stent could not be pushed from the shapeable microcatheter in the patient's body.It was thought to be a problem with the product quality that led to this issue.The navien was replaced and the product could be delivered normally.The resistance in the catheter was in the middle section.The catheter was flushed continuously with a heparinized saline.It was unknown if the catheter or pushwire were 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 reported.The angiographic result post procedure showed slowed down blood flow.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 5mm and a 4mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Ancillary devices include: short sheath and a phenom 27 microcatheter.

• Brand Name: PIPELINE FLEX
• Common Device Name: 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: 15078470
• Report Number: 2029214-2022-01210
• Device Sequence Number: 14619531
• Product Code: OUT
• UDI-Device Identifier: 00847536015456
• UDI-Public: 00847536015456
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2024
• Device Model Number: PED-350-30
• Device Catalogue Number: PED-350-30
• Device Lot Number: B191457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male