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

Model Number	PED-500-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
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 a report that the pipeline could not be opened, and it could not be opened after repeated adjustments.The tip end had burrs due to repeated adjustments.There were no patient symptoms or complications associated with the event.The angiographic result post procedure was normal.It was unknown if a dapt (dual antiplatelet treatment) was administered.The pipeline was not used for an indication that was off-label.The pipeline was prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a amorphous, unruptured aneurysm in the c6 with a max diameter of 7mm and a 6mm neck diameter.It was noted the patient's vessel tortuosity was normal.
Event or Problem Description
Additional information received reported that the pipeline had not been placed in a vessel bend when it failed to open.Repeated recovery was attempted, increased or decreased tension during operation to try to open.
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 device and marksman micro catheter were returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within an opened pipeline flex inner pouch.Visual inspection/damage location details: no damages or irregularities were found with the marksman micro catheter hub.The pipeline flex braid and the distal wire were found stuck within the marksman hub.Dried blood was found within the hub.The marksman micro catheter was found kinked at ~13.1cm from the proximal end.No damages or irregularities were found with the marksman micro catheter distal tip and marker band.The braid and distal tip were retracted out of the hub against some resistance.The pipeline flex pusher was found kinked at ~46.0cm from the proximal end.The hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.No damages were found with the distal marker, re-sheathing marker, resheathing pad or with the proximal bumper.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil was found intact and unstretched.The proximal braid end was found fully opened and frayed.The distal braid was found tapered and covered with dried blood.The dried blood was dissolved, and the distal braid fully opened.The distal braid was found damaged and frayed.Testing/analysis: the marksman micro catheter total length was measured to be ~159.7cm and the usable length was measured to be ~152.1cm.As the model and lot numbers were not reported, conformation to specification could not be confirmed.Conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ was confirmed.The cause of the distal end tapering during analysis is the dried blood found on the braid.It is unknown whether the blood was coagulated during the procedure.Other possible causes during procedure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel braid, presence of other indwelling stents or inappropriate anatomy.The braids were found damaged.Potential causes for braid damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, or deploying/resheathing braid against resistance.Customer reported patient vessel tortuosity as normal, devices were prepared and flushed per ifu, and device not placed in a vessel bend.There is no indication that the event is related to a potential manufacturing issue.There was no damages or irregularities found with the marksman that would contribute towards the incomplete open.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: 13040608
• Report Number: 2029214-2021-01631
• Device Sequence Number: 1792548
• Product Code: OUT
• UDI-Device Identifier: 00847536019720
• UDI-Public: 00847536019720
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2022

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: 08/02/2024
• Device Model Number: PED-500-20
• Device Catalogue Number: PED-500-20
• Device Lot Number: B244042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/24/2021; 02/07/2022
• Initial Report FDA Received Date: 12/19/2021
• Supplement Report FDA Received Date: 01/20/2022; 02/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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: 74 YR
• Patient Sex: Male