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

Model Number	PED-350-25
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the tip end of the pipeline could not be opened. the device was replaced, and the patient did not experience any injury or complications.Angiographic results post procedure showed that the embolization was good.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, saccular aneurysm located in the ophthalmic artery.The max diameter was 3.4mm, and the neck diameter was 2.6mm.The patient's vessel tortuosity was normal.The landing zone was 3.21mm distal and 3.55mm proximal.
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 reported the pipeline was not positioned in a bend.
Additional Manufacturer Narrative
B5 updated with additional information received.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
H3: product analysis #281935371:¿equipment used: video inspection system (m-85519), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) ¿drawing(s) referenced: n/a ¿ as found condition: the pipeline flex device was returned for analysis within a shipping box; within a plastic bio-pouch; and within an opened pipeline flex inner pouch and a dispenser coil.There was no catheter returned with the pipeline flex.¿ visual inspection/damage location details: no bends or kinks were found with the pipeline flex pusher.The pipeline flex distal hypotube does not appear to be stretched and the ptfe shrink tubing was intact.The proximal bumper, re-sheathing pad and re-sheathing marker were found intact.The distal and proximal dps restraints were found to be intact.The ptfe sleeves were found intact with no signs of damage.No damages were found with the tip coil.The pipeline flex braid ends were found moderately frayed; however, both ends of the braid were found open.As the pipeline flex braid was returned detached from the pushwire, the distal and proximal ends of the braid were unable to be identified.No other anomalies were observed.¿ testing/analysis: n/a ¿ conclusion: based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open¿ could not be confirmed.The event cause could not be determined as the distal and proximal ends of the pipeline flex braid appeared fully opened and moderately damaged.There was no non-conformance to specification that may have contributed to the failure to open issue.(nikkhs2 2022-10-28) 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.

• Brand Name: PIPELINE FLEX
• 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: 15385799
• Report Number: 2029214-2022-01520
• Device Sequence Number: 5429731
• Product Code: OUT
• UDI-Device Identifier: 00847536015425
• UDI-Public: 00847536015425
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2022

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: 06/08/2024
• Device Model Number: PED-350-25
• Device Catalogue Number: PED-350-25
• Device Lot Number: B218641
• 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: 09/03/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 10/31/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 09/29/2022; 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• 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: 58 YR
• Patient Sex: Female