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

Model Number	PED-275-18
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information reporting that during the procedure, the tip of the pipeline stent could not be opened.The pipeline was replaced to complete the procedure.It was noted the pipeline and all accessory devices were prepared according to the instructions for use (ifu).There was no harm or injury to the patient who was undergoing a procedure to treat a ruptured amorphous right ophthalmic artery segment aneurysm.The aneurysm max diameter was 6.12mm and the neck diameter was 4.65mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered.After replacement of the complaint pipeline, post-procedure angiography should completed embolization and contrast retention.Ancillary devices: navien 6f 115cm catheter, marksman microcatheter.
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 distal end of the pipeline could not be opened normally and was deformed.The pipeline was placed in a straight segment at the lesion site.Tried to recycle and re-deployed 1 time, still couldn't be opened.No obvious resistance during delivery.Ancillary devices: marksman model fa-55150-1030 lot number: 221199918.
Additional Manufacturer Narrative
As found condition (condition of returned device): a pipeline flex embolization device and a marksman catheter were returned for analysis within a shipping box; within an opened pipeline flex embolization device inner pouch and within a plastic bag.Visual inspection/damage location details: the distal end of pipeline flex was found to be stuck within hub of marksman catheter.The marksman catheter was then dissected (cut) for removal and further analysis of pipeline.(pli-10) the pipeline flex pushwire was found to be broken and not returned.The pipeline flex embolization device was found be broken at distal end of hypotube.The ptfe shrink tubing was found to be not returned.The proximal bumper, pad and re-sheathing marker were found to be intact.The dps restraints/sleeves were found to be intact.The tip coil was found to be damaged.Proximal braid end was found to be opened and frayed.Distal braid end was found to be opened and frayed.(pli-20) no device malfunction was reported with the marksman catheter.No damages were found with the marksman hub.The marksman total length was measured to be ~159.1cm.The useable length was measured to be ~151.5cm.The catheter body was found to be kinked at ~4.8cm from distal tip and kinked at proximal end of hub.No damages were found with the distal tip.No other anomalies were observed.Testing/analysis (including sem reports): the broken distal hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the broken hypotube end shows tin (sn) was detected on the surface.The dimples features observed on the fracture surface indicate a ductile overload (bending/tearing) type failure.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was unable to be confirmed as each braid end of the pipeline flex braid were found to be fully open and root cause was unable to be determined.Based on the device analysis and reported information, the customer¿s report of ¿pipeline damaged during delivery/retrieval¿ was confirmed.However, the root cause could not be determined.Possible causes for ¿pipeline damaged during delivery/retrieval¿ include high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/re-sheathing braid against resistance and use of incompatible device.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: 13366406
• Report Number: 2029214-2022-00105
• Device Sequence Number: 19821520
• Product Code: OUT
• UDI-Device Identifier: 00847536014640
• UDI-Public: 00847536014640
• 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): 04/27/2022

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: 02/12/2024
• Device Model Number: PED-275-18
• Device Catalogue Number: PED-275-18
• Device Lot Number: B160818
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 03/02/2022; 04/26/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/23/2022; 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2021
• 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: 52 YR
• Patient Sex: Male