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

Model Number	PED2-425-12
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex w/ shield pusher and phenom-27 micro catheter were returned for analysis.No flash or voids molded were found within the phenom-27 micro catheter hub.No damages or anomalies were found with the hub.The pipeline flex w/ shield pusher was found extending out of the hub ~45.9cm.The distal ~3.2cm of the phenom-27 micro catheter body was found accordioned.The distal tip was found damaged.The tip coil and dps sleeves were found extending out of the micro catheter.The pipeline flex w/ shield pusher could not be retracted back within the micro catheter as the dps sleeves appears to be stuck at the damaged tip.The pusher was advanced out distally instead against resistance.Dried blood was found on the pipeline flex w/ shield pusher and within the micro catheter.No damages were found with the pipeline flex w/ shield proximal pusher.The hypotube was intact and unstretched and ptfe shrink tubing was found undamaged.No damages were found with the distal marker, re-sheathing marker, resheathing pad or with the proximal bumper.The distal and proximal dps restraints were found to be intact.The ptfe dps sleeves were found slightly damaged.The tip coil was found undamaged.The braid was not returned for analysis.The phenom-27 micro catheter total length was measured to be ~155.9cm and the usable length was measured to be ~149.3cm, which is within specification (specification: total (ref) = 156.5cm; usable = 150cm ± 5cm).The inner diameter was measured to be 0.027¿, at both ends which is within specification and compatible for use with the pipeline flex w/ shield.The micro catheter was flushed, and water exited out the distal end.The catheter was then tested by running an in-house 0.0265¿ mandrel through microcatheter.The mandrel passed through the catheter hub, catheter body and exited the distal tip with resistance encountered.Blood was found on the mandrel when retracted back out.Based on the analysis findings, the pipeline flex w/ shield and phenom-27 were confirmed to have ¿delivery system stuck during retraction¿, ¿resistance during retrieval¿ and ¿catheter resistance¿ as resistance was found with the returned pipeline flex w/ shield pusher within the distal segment of the phenom-27 catheter.It is likely the damages found to the distal tip and the dps sleeves contributed towards the resistance.Possible causes for damages are patient vessel tortuosity, delivery system removed aggressively, catheter entrapment or user retrieves device against resistance.The coagulated blood was found to contribute towards resistance during resistance testing, however, it is unclear whether the blood had coagulated during the procedure.The micro catheter was found accordioned near the tip.The likely cause is the attempt to retract the pusher within the micro catheter against the reported resistance.As the pipeline flex w/ shield braid was not returned for analysis, any contribution of the pipeline flex w/ shield braid towards the resistance and damage could not be determined.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 information that upon retrieval of the pipeline wire and phenom 27 microcatheter experienced significant resistance and was unable to safely recapture the deliver wire.The patient was undergoing aneurysm embolization.Previously ruptured aneurysm treated in (b)(6) 2021 coil embolization emergently.The location was the internal carotid artery (ica) in the right pcom.It was amorphous with a status of unruptured.The mas diameter was 6 x 7mm and a neck of 5mm.The distal landing zone was 4.1mm and the proximal was 4.3mm.Vessel tortuosity was normal.The access vessel was the right ica with a diameter of 4.1mm.Dual antiplatelet treatment was administered.Pru level was 8.The angiographic result post procedure was excellent aneurysm embolization.The devices were prepared as indicated in the instruction for use (ifu).  the doctor successfully advanced the pipeline shield device and recapture one time to adjust position; successfully deployed the device.However, upon retrieval of wire and microcatheter experienced significant resistance and was unable to safely recapture the deliver wire.Pulled everything out as a single unit.No symptoms were reported.Ancillary devices: ballast 90 guidecatheter, sofia 115 distal access catheter.Additional information was received indicating the resistance was at the distal end of the catheter.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: 14118784
• Report Number: 2029214-2022-00641
• Device Sequence Number: 14536743
• Product Code: OUT
• UDI-Device Identifier: 00763000284411
• UDI-Public: 00763000284411
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/15/2022

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: 08/16/2024
• Device Model Number: PED2-425-12
• Device Catalogue Number: PED2-425-12
• Device Lot Number: B251518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2022
• Initial Report FDA Received Date: 04/15/2022
• Date Device Manufactured: 08/17/2021
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 67 KG