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

Model Number	PED2-500-14
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id fg15160-0615-1s (lot: 227343021); implant date n/a; explant date n/a 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 pipeline failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right internal carotid artery.Landing zone: distal: 3.68 mm and proximal: 4.98 mm.It was noted the patient's vessel tortuosity was normal.The angiographic result post procedure was good.It was reported that pipeline was prepped appropriately.Upon attempting to deploy the device, there appeared to be a 'ribboning' effect and lack of opening between the distal and middle sections.Re-sheathing, forward pressure on microcatheter, opening a large amount of device, and loading/reducing load techniques were attempted with no success.After these techniques failed to open the same area of the pipeline, the physician requested another pipeline of the same size.He successfully removed the pipeline by re-sheathing via the appropriate phenom 27 catheter.The new pipeline was successfully deployed with standard technique and much less manipulation.It was reported the pipeline failed to open between the distal and middle segment.The pipeline was positioned in a middle bend.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed more than 2 times.There were no additional steps or other devices required to open the pipeline.The pipeline was removed from the patient by resheathing and removing with the microcatheter.The pipeline was not used for an indication that is off-label.The pipeline and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a bmx 81 guide catheter.
Additional Manufacturer Narrative
Product analysis # 706188484:¿ equipment used: vis (m-78210), 203cm ruler (m-83361) ¿ as found condition: the pipeline flex embolization device and phenom 27 catheter were returned for analysis within a shipping box, a plastic bio-pouch, and an opened phenom 27 inner pouch (227343021).¿ damage location details: the pipeline flex embolization device was returned within the phenom 27 catheter.The pipeline flex pusher was found extending out from within the phenom 27 catheter hub for ~36.5cm.No damages were found with the phenom 27 catheter hub.No bends or kinks were found with the phenom 27 catheter body.No bends or kinks were found with the pipeline flex pusher.The pusher resheathing pad and sleeves were found to be in good condition.Both ends of the pipeline flex braid were found open, but frayed.Clotted blood was found within the pipeline flex braid.Dried blood was found on the pipeline flex pusher tip coil.¿ testing/analysis: the pipeline flex embolization device was pushed out from within the phenom 27 catheter with resistance.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿failure/incomplete to open¿ report could not be confirmed as the returned pipeline flex braid was found open.Possible causes of ¿failure/incomplete open¿ include patient vessel tortuosity, damaged braid, or deploying the braid in vessel bend.It is likely the damage (fraying) of the pipeline flex braid and the placement of the braid in a vessel bend contributed to the reported failure to open.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received that the cause of the failure to open was not determined.
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.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: 18627482
• Report Number: 2029214-2024-00220
• Device Sequence Number: 18165927
• Product Code: OUT
• UDI-Device Identifier: 00763000284695
• UDI-Public: 00763000284695
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2024

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: 04/26/2026
• Device Model Number: PED2-500-14
• Device Catalogue Number: PED2-500-14
• Device Lot Number: B555681
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 01/23/2024; 03/19/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/01/2024; 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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: 68 YR
• Patient Sex: Male