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

Model Number	PED2-475-30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the doctor prepped patient and gained access into right femoral artery.Neuron max advanced into left internal carotid.Phenom plus and xt-27 were then advanced for the procedure.Xt-27 was parked in the left middle cerebral artery.First device prepped was a surpass evolve stent to treat a left ophthalmic aneurysm.The surpass stent failed to open and appose the vessel wall.The surpass evolve stent was re sheathed and removed from the patient.Dr (b)(6) then opened and prepped pipeline shield 4.75x30.The pipeline was advanced in the xt-27 catheter and attempted to deploy across the aneurysm.During the attempt to deploy the stent, the stent came off the re sheathing pad before the mc had reached the point of no return.Pipeline stent prematurely moved off the re sheathing pad inside the microcatheter during attempted deployment.Approximately half of the stent was still constrained by the mc.Dr (b)(6) was able to remove the mc and the stent together as a system without deployment of the pipeline.Another surpass evolve was opened and successfully implanted across the aneurysm.There was a good angiographic result and the patient did not suffer any injury from this event the pipeline was not used for an indication that is not approved (off-label).The pipeline and any accessory devices were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Dapt was administered and pru level was 80.Good angiographic result post procedure.  the patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left internal carotid artery (ophthalmic) with a max diameter of 14mm and a 8mm neck diameter.Landing zone was 4.6mm distal and 4.8mm proximal.It was noted the patient's vessel tortuosity was severe.  ancillary devices include a neuron max sheath, phenom plus guide catheter, xt-27 microcatheter, and aristotle 024 guidewire.
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.
Additional Manufacturer Narrative
Product analysis #706123455: equipment used: video inspection system (m-85519), camera (panasonic lumix dmc-zs5); ruler (m-83361).Drawing(s) referenced: n/a.As found condition: the pipeline flex shield braid was returned within the inner pouch; inside of a biohazard bag and a shipping box.There was no pushwire or catheter returned with the braid.Visual inspection/damage location details: the distal end of the braid was not opened due to damaged braid.The proximal end of the braid was found fully opened and frayed.No other anomalies were observed.Testing/analysis: n/a.Conclusion: based on the returned device, the customer complaint was confirmed as pipeline flex shield braid was detached from the pushwire.However, the cause could not be determined.In addition, the distal end of the braid was not opened due to damaged braid.The cause of failure to open could not be determined.Possible causes of failure to open include vessel tortuosity and damaged braid.Ls 2024-02-01 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 reported the healthcare provider (hcp) communicated to me that the push wire was not rotated during attempted deployment of this device.The push wire was pulled back during attempted deployment.During initial deployment the hcp decided to reposition the device.The push wire was pulled back for recapture and repositioning.The hcp communicated after this repositioning he then attempted to deploy the device again.During the attempt is when the device came off the re sheathing pad.

• 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: 18480785
• Report Number: 2029214-2024-00074
• Device Sequence Number: 6407871
• Product Code: OUT
• UDI-Device Identifier: 00763000284657
• UDI-Public: 00763000284657
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 05/31/2026
• Device Model Number: PED2-475-30
• Device Catalogue Number: PED2-475-30
• Device Lot Number: B572900
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 74 KG