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

Model Number	PED-500-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
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 proximal segment of the pipeline failed to open.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ophthalmic artery segment.The max di ameter was 11.5mm, and the neck diameter was 8.89mm.The patient's vessel tortuosity was moderate.The landing zone was 4.47mm distal and 4.79mm proximal.It was reported that device was delivered to the distal end of the m2, and when the microcatheter was withdrawn, the tip of the stent could not be opened normally.After 3 repeated attempts, the tip still could not be opened.The device was not placed in a bend, and more than 50% had been deployed when it failed to open.The pipeline had been resheathed 2 or less times, and no other steps were taken to open the device.The stent was removed and replaced, and treatment was changed to stent-assisted spring coil embolization. angiographic results post procedure showed that the aneurysm was completely embolized. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a 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.
Additional Manufacturer Narrative
H3: a pipeline flex embolization device was returned for analysis.The marksman catheter used during the event was not returned.No bends or kinks were found with the pipeline pushwire.The hypotube was found to be stretched with ptfe pulled back.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found to be intact.The tip coil was found to be intact.The pipeline flex braid was not returned.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open proximal¿ was unable to be confirmed as the braid was not returned.Possible factors for failure to open is the result of damaged braid or braid improperly sized to anatomy.Furthermore, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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.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
• MDR Report Key: 12166519
• Report Number: 2029214-2021-00867
• Device Sequence Number: 19778720
• Product Code: OUT
• UDI-Device Identifier: 00847536019782
• UDI-Public: 00847536019782
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2021

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: 02/10/2024
• Device Model Number: PED-500-30
• Device Catalogue Number: PED-500-30
• Device Lot Number: B159375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 07/16/2021; 10/06/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/11/2021; 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 62