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

Model Number	PED-450-35
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
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 middle section of the pipeline could not be opened.The pipeline and phenom 27 catheter were replaced with similar models and the surgery was completed.The pipeline was 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 2 times.There were no additional steps or other devices required to open the device.The pipeline was resheathed and removed with the microcatheter.The devices were prepared as indicated in the ifu.There were no symptoms or complications associated with the event.The patient underwent blood flow guiding device for treatment of an aneurysm.The patient had moderate vessel tortuosity.Ancillary devices include: 6f long sheath, 5f 115navien, echelon 10 microcatheter, synchro 14 guidewire and minimally invasive coils.
Additional Manufacturer Narrative
Product analysis: as found condition: the pipeline flex embolization device and marksman catheter were returned for analysis within a shipping box, within a plastic bio-pouch, and within an opened pipeline flex inner pouch (b222613).Visual inspection/damage location details: the pipeline flex pusher was found bent at ~133.0cm and ~187.0cm from the proximal end.The pusher distal hypotube was found stretched with the shrink tubing pulled back from the proximal bumper.The pusher resheathing pad was found in good condition.The pusher distal core wire was found broken.The marksman catheter was flushed, the pipeline flex pusher sleeves and tip coil were flushed out of the catheter tip.The distal core wire was found broken proximal to the sleeves.The pusher sleeves and tip coil were found in good condition.The pipeline flex braid was not returned.Testing/analysis: the broken pipeline flex distal core wire was sent out for sem (scanning electron micrographic) failure analysis.Per the analysis report, the wire failed via torsional overload.Conclusion: based on the device analysis and reported information, the customer¿s ¿failure/incomplete to open at middle section (hourglass shape)¿ report could not be confirmed.Possible causes of ¿failure/incomplete to open¿ include patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents, or inappropriate anatomy.The pipeline flex braid was not returned; therefore, an analysis could not be performed, and any contributing factors could not be assessed.It is possible the patient¿s ¿moderate¿ vessel tortuosity and the placement of the braid in a vessel bend contributed to the event.However, the cause could not be determined.Regarding the distal core wire separation, possible causes include patient vessel tortuosity, resistance of delivery wire during delivery/retrieval, over-manipulation, user resheaths more than 2 times.The pipeline was resheathed less than or equal to 2 times and no resistance was reported.It is possible the patient¿s ¿moderate¿ vessel tortuosity and over-manipulation contributed to the separation.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: 14806579
• Report Number: 2029214-2022-01061
• Device Sequence Number: 11973059
• Product Code: OUT
• UDI-Device Identifier: 00847536016569
• UDI-Public: 00847536016569
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 06/16/2024
• Device Model Number: PED-450-35
• Device Catalogue Number: PED-450-35
• Device Lot Number: B222613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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: 54 YR
• Patient Sex: Female