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

Model Number	PED2-450-35
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline failed to open and was stuck at the catheter hub.The patient was undergoing neuro-intervention, blood flow guiding dense mesh stent implantation for treatment of a saccular, unruptured aneurysm in the right internal carotid artery ophthalmic segment with a max diameter of 8.6 mm and a 7.1 mm neck diameter.Landing zone: distal: 4.76 mm and proximal 4.28 mm.The accessed vessel was the radial artery with a diameter of 2.5 mm.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered.The pru level was within the normal value range.The angiographic result post procedure showed the blood vessels were smooth and everything was normal.It was reported that radial artery puncture, tethys 115 reached the level of the cavernous sinus, and phenom 27 went as far as middle cerebral artery m2.Ped2-450-35 was delivered smoothly, m1 segment of middle cerebral artery was opened, and the deployment was more than 15mm, but the ped tip still could not be opened well.  after waiting, it opened slightly, but the shape of the tip didn't look very normal.Pulled it back and positioned and found that the shape of the tip still didn't look normal.Suspected there was a risk of damage.  repeated observations from multiple angles revealed that there was still a risk of damage.Finally, the phenom27 and ped2-450-35 were removed from the body as a whole and stuck at the hub.When it was pulled out with force, the tip was found to be damaged.So reopened another phenom27 and pushed the catheter to go upper, and then reopened a ped2-475-30.This time it went smoothly, the tip was opened smoothly and attached to the wall, and the surgery went smoothly.It was reported the pipeline failed to open in the distal section.The pipeline was not positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed less than or equal to two times.It was attempted to deploy a longer distance, wait a while, and give tension in order to open the pipeline.The pipeline was removed from the patient by taking it out directly from the patient.The pipeline was not used for an indication that is off-label.The pipeline and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a 6f radial artery puncture sheath, jiaqi tethys 115 cm guide catheter, phenom 27 microcatheter, synchro 0.014 in guidewire, liquid embolic,  2 axium 8-30-3d coils, axium 7-20-3d coil, and 2 axium6-20-3d coils.
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 226576371); product type: ; implant date n/a; explant date n/a 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.
Additional Manufacturer Narrative
Product analysis: ¿as found condition: the phenom 27 catheter, pipeline flex shield braid and non-medtronic guidewire were returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex shield pushwire was not returned for analysis.Therefore, any contributing factors could not be assessed.¿damage location details: the distal and proximal ends of the pipeline flex shield braid were fully opened and damaged.No flash or voids molded were observed in the hub.The catheter body was found to be kinked at ~39.0cm from proximal end.The catheter distal tip and marker band were found to be accordioned.No other anomalies were observed.No damage was found with the returned non-medtronic guidewire.¿testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and water was exited out from the distal tip.An in-house 0.026" mandrel was inserted through the catheter hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged locations.In addition, the pipeline flex shield braid was pushed out from catheter lumen.¿conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter kinked/damage¿ and (catheter resistance at hub) were confirmed.From the damages seen on the catheter body (accordioning/kinking) and pipeline flex braid(fraying); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex shield through the phenom 27 catheter against resistance.However, based on the on the analysis findings, the pipeline flex shield was not confirmed to have failure to open at the distal end as the distal and proximal ends of the pipeline flex shield braid were found fully opened and damaged.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
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
Additional information received clarified the tip of the pipeline was damaged.

• 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: 18414402
• Report Number: 2029214-2023-02488
• Device Sequence Number: 16877173
• Product Code: OUT
• UDI-Device Identifier: 00763000284572
• UDI-Public: 00763000284572
• 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: 2023
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 03/20/2024

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: 04/30/2026
• Device Model Number: PED2-450-35
• Device Catalogue Number: PED2-450-35
• Device Lot Number: B557008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 03/08/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 01/29/2024; 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ..
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 52 KG