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

Model Number	PED-425-12
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A pipeline flex embolization device and a phenom-27 catheter were returned for analysis.The inner diameter (id) of the phenom-27 catheter was found to be 0.027¿.Per pipeline flex embolization device instructions for use (ifu): ¿the pipeline embolization device is designed to be delivered through a compatible micro catheter of 0.027¿ inside diameter.Therefore, the phenom-27 catheter was found to be compatible for use with the pipeline flex.The pipeline flex pushwire was found to be extending ~58.5cm from hub.The pipeline flex embolization device was then removed from the phenom-27 catheter.No bends or kinks were found with the pipeline pushwire.The hypotube was found to be intact with ptfe pulled back and blood residue.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found to be damaged.The tip coil was found to be damaged.The pipeline braid was not returned.No other anomalies were found with the pipeline device.The pipeline flex pushwire was found to be extending ~58.5cm from hub.No damages were found with the phenom hub.The phenom total length was measured to be ~151.7cm.The useable length was measured to be ~145.2cm which was found to be within specification.The catheter body was found to be accordioned at ~145.0cm for ~5.0cm from distal tip.No damages were found with the distal tip.The pipeline flex was then removed from the catheter.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was confirmed.It is likely the damages to the catheter body (accordioned) contributed to the resistance.Possible contributing factors to ¿catheter resistance¿ include the use of an incompatible device, severely tortuous patient anatomy, and insufficient catheter flush.Based on the device analysis and reported information, the customer¿s report of ¿delivery system stuck during retraction¿ was confirmed.It is likely the damages to the catheter body (accordioned) contributed to the resistance.Possible contributing factors to ¿delivery system stuck during retraction¿ include high force delivery/retrieval, catheter damage, and lack of a continuous flush.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the pipeline delivery system became stuck in the phenom microcatheter during retraction.The patient was undergoing treatment for unruptured, saccular aneurysm located in the ophthalmic segment of the left ica.The max diameter was 6mm, and the neck diameter was 4mm.The patient's vessel tortuosity was moderate.The landing zone was 3.2mm distal and 4.2mm proximal.The access vessel was the left ica, which was 4.2mm in diameter.Dual antiplatelet treatment was administered, and the pru level was 26.It was reported that the pipeline was successfully deployed across the aneurysm.The physician went through the device to capture the distal pipeline wire.Retrieval was tough, and the wire became stuck in the catheter.The wire and catheter were removed, and the patient did not experience any injury or complications.The pushwire was not rotated during removal, and there was no damage to the catheter.Angiographic results post procedure showed good placement.The patient woke up without incident and returned to baseline.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a navien 072 guide catheter.Additional information received reported that the pipeline wire became stuck in the distal portion of the catheter.

• 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: 12833170
• Report Number: 2029214-2021-01494
• Device Sequence Number: 4472530
• Product Code: OUT
• UDI-Device Identifier: 00847536016088
• UDI-Public: 00847536016088
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 11/03/2023
• Device Model Number: PED-425-12
• Device Catalogue Number: PED-425-12
• Device Lot Number: B111802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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: 43 YR
• Patient Sex: Female