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

Model Number	PED2-475-16
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
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
Medtronic received a report that the pipeline pushwire broke.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left internal carotid artery (ica) with a max diameter of 3.5 mm and a 2.9 mm neck diameter.Landing zone: distal: 3.25 mm and proximal: 4.72 mm.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered.The pru level was 70.The angiographic result post procedure showed a normal angio, with pipeline embolization of ica aneurysm.It was reported that normal pipeline deployment of a 4.75 x 16 mm device.Distal end was slightly lazy, but open.Upon pulling the pusher wire out of the catheter, the physician noticed that the distal end of the pusher wire (sleeves and lead wire) were broken off and stuck in the rhv.It was reported pushwire break occurred with the tip coil detached.The broken segment of the pushwire was removed from the patient.There was no friction or difficulty.The pipeline was implanted in the patient.It was reported this was a normal deployment, with no resheathing, issue did not occur until the pusher wire was being removed.Patient is doing well.The pipeline was not used for an indication that is off-label.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a balt ballast guide catheter, phenom 27 microcatheter, and stryker synchro 2 guidewire.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information was received reporting the cause for the break was not determined, physician states there was no abnormal resistance.
Additional Manufacturer Narrative
Product analysis: as found condition: the pushwire and rhv valve were returned inside a sealed bio-hazard bag and a shipping box.No pipeline flex shield braid was returned with the pushwire as it was implanted in the patient.Damage location details: the tip coil and sleeves were stuck inside the rhv valve.The rhv valve was flushed with water to remove the tip coil and sleeves.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The pushwire appeared to be separated proximal to the dps sleeves.The distal hypotube appeared to be stretched, but the ptfe shrink tubing remained intact.The broken end was sent out for sem analysis.No other anomalies were observed.Testing/analysis: according to the sem results, the broken end failed via torsional overload.Conclusion: based on the returned device, the customer complaint was confirmed as the pushwire separated proximal to the dps sleeves.Per the sem results, the broken end failed via torsional overload.Additionally, from the damages seen on the hypotube (stretching) and pushwire (separating), it appears that high force was used.The customer reported that there was no friction or difficulty.In addition, the vessel tortuosity was moderate, ruling out vessel tortuosity as a potential cause.The root cause could not be determined.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.

• 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: 18896305
• Report Number: 2029214-2024-00423
• Device Sequence Number: 18062959
• Product Code: OUT
• UDI-Device Identifier: 00763000284619
• UDI-Public: 00763000284619
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/23/2024

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 Model Number: PED2-475-16
• Device Catalogue Number: PED2-475-16
• Device Lot Number: B658692
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 03/14/2024; 05/21/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/03/2024; 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Female