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

Model Number	PED2-450-12
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
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 internal carotid artery with a max diameter of 3 mm and a 3 mm neck diameter.Landing zone: distal: 4 mm and proximal: 4.4 mm.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered.The angiographic result post procedure showed a good outcome.It was reported that when the dr.Was deploying the pipeline, he was wagging to get the distal tip open and when he was pushing the wire, it broke off the device.About 1/3 of the device was deployed and he was able to pull the device and phenom 027 back into the navien 058.No harm was done, but the fact that it broke scared him.It was reported the pushwire broke in the proximal section.The broken segment of the pushwire was removed from the patient.The broken segment was removed with the catheter.There was no friction or difficulty.The pipeline was removed 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).No patient symptoms or further complications were reported as a result of this event.  ancillary devices include a merit short sheath, rist 071 sheath, navien 058 125 cm guide catheter, phenom 27 microcatheter, synchro 014 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.
Event or Problem Description
Additional information was received that the cause of the break was not determined.
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: ¿ as found condition: the pipeline flex shield embolization device and phenom 27 catheter were returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex shield device was returned within phenom 27 catheter.¿ damage location details: the pushwire was returned extending out from catheter hub.In addition, the distal braid, sleeves, and tip coil were deployed from catheter distal tip.No break/separation was found with returned pushwire.No bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the proximal bumper, re-sheathing pad, re-sheathing marker, distal marker, and tip coil.The distal and proximal ends of pipeline flex shield braid were found fully opened and damaged.No flash or voids molded were observed in the hub.No damage was found with hub.No kink or damages were found with catheter body.¿ testing/analysis: na ¿ conclusion: based on the device analysis and reported information, the customer¿s report of ¿pushwire break/separation¿ could not be confirmed.No defect was found with pushwire.No break/separation was found with returned pushwire.However, 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: 18705971
• Report Number: 2029214-2024-00286
• Device Sequence Number: 20402189
• Product Code: OUT
• UDI-Device Identifier: 00763000284503
• UDI-Public: 00763000284503
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 04/17/2024

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: PED2-450-12
• Device Catalogue Number: PED2-450-12
• Device Lot Number: B648099
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 02/14/2024; 03/28/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/13/2024; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG