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

Model Number	PED-375-35
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline became stuck in the middle of the phenom 27 microcatheter.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left ophthalmic artery segment.The max diameter was 18.7mm, and the neck diameter was 12.1mm.The patient's vessel tortuosity was severe.The landing zone was 2.83mm distal and 3.47mm proximal.The access vessel was the right femoral artery, which was 7.3mm in diameter. dual antiplatelet treatment was administered at a routine level.It was reported that the pipeline could not be pushed forward or withdrawn.A continuous flush had been administered.There was no damage to the catheter or pushwire. the device was replaced, and the patient did not experience any injury or complications.Angiographic results post procedure showed that the blood flow had slowed down.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a cook 6 sheath, navien 5f guide catheter, and synchro 2 guidewire.
Additional Manufacturer Narrative
The pipeline flex embolization device and phenom 27 catheter were returned for analysis.No bends or kinks were found with the pipeline flex pusher.However, the distal pusher hypotube was found stretched.The pusher distal core wire was found broken proximal to the ptfe sleeves.The phenom 27 catheter was examined.The pipeline flex braid was found stuck within the hub.The phenom 27 catheter body was found flattened from ~24.0cm to ~19.5cm from the distal tip.No damage was found with the phenom 27 distal marker/tip.The phenom 27 catheter was dissected, the braid and ptfe sleeves with tip coil were removed from within the proximal end of the catheter.The pipeline flex braid ends were found open but damaged (frayed).The pipeline flex distal core wire was confirmed to have separated proximal to the ptfe sleeves.No damage was found with the ptfe sleeves and tip coil; however, a dried residue (possibly saline) was found on the surface.The pipeline flex pusher distal core wire was sent out for sem (scanning electron micrographic) f ailure analysis.Per the analysis report, the wire failed via torsional overload based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ was confirmed.The investigation determined that this event was similar to events 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 patient¿s ¿severe¿ vessel tortuosity contributed to damage found with the phenom 27 catheter (flattening), causing resistance during delivery of the pipeline flex device.Regarding the broken pipeline flex pusher distal core wire, 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 formal investigation, pusher separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity.It is also likely the patient¿s ¿severe¿ vessel tortuosity and the reported resistance contributed to wire separation.In addition, as the core wire failed via torsional overload and the hypotube was stretched, it is likely some excessive force was used.If information is provided in the future, a supplemental report will be issued.

• 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: 13367879
• Report Number: 2029214-2022-00107
• Device Sequence Number: 14451034
• Product Code: OUT
• UDI-Device Identifier: 00847536015753
• UDI-Public: 00847536015753
• 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: 2021
• Device Explanted Year: 2021
• 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): 01/27/2022

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: 02/16/2024
• Device Model Number: PED-375-35
• Device Catalogue Number: PED-375-35
• Device Lot Number: B162002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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: 71 YR
• Patient Sex: Female