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

Model Number PED-450-20

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2023

Event Type  malfunction  

Event Description

Medtronic received a report that the doctor deployed some of the product at the middle cerebral artery and then pulled it to the lesion.After the microcatheter was withdrawn while the delivery guidewire was fixed (not exceeding the retrieved mark point), the delivery guidewire could not control the stent, and the microcatheter and the stent were withdrawn together in the blood vessel.After the whole part was withdrawn, it was found that the stent and the delivery guidewire had been separated, and the surgery was continued after the stent was replaced.The pipeline was used for an indication that is approved (on-label).The pipeline and any accessory devices were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured right ophthalmic segmental aneurysm with a max diameter of 6.5mm and a 3.2mm neck diameter.The landing zone was 3.81mm at the distal end and 4.41mm at the proximal end.It was noted the patient's vessel tortuosity was minimal.No patient symptoms or further complications were reported as a result of this event.

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.

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 Description

New information was received.To clarify the report of "the stent and the delivery guidewire had been separated" was that when the surgeon adjusted the position of the stent by controlling the delivery guidewire, it was unable to reach target position (microcatheter was not withdrawn to retrieval mark point).Part of the pipeline or delivery wire was not fractured or separated from the rest.It was observed "not broke".According to the operation, the combination of the recovery pad and the stent delivery guidewire was unstable, which led to the early separation during operation and the loss of control of the stent.The cause of the event was not determined.

Manufacturer Narrative

H3: product analysis of ped-450-20, lot# b343501 visual inspection/damage location details: no damages were found with the pipeline flex proximal pusher.The hypotube was intact and unstretched and ptfe shrink tubing was found undamaged.No damages were found with the pad restraint, resheathing pad or with the proximal bumper.No damages or irregularities were found with the dps sleeves, dps restraints and tip coil.Both braid ends were found fully opened, damaged, and frayed.Testing/analysis: the resheathing pad outer diameter was measured to be 0.0230¿ (0.5842mm), which is within specification (specification: 0.5779mm - 0.5880mm).Conclusion: based on the analysis findings, the customer report of ¿device opens prematurely¿ was confirmed as the braid was found already separated from the resheathing pad.Possible causes for failure are incompatible micro catheter, resistance during delivery, high force delivery, operator did not have the sheath properly seated in hub of microcatheter, over-manipulation, pushwire was torqued/pulled back during insertion or advancing ped inside microcatheter, or user resheaths device more than two times.Customer reported devices per prepared per ifu and patient vessel tortuosity as minimal.The customer report of ¿difficult placement/positioning¿ could not be confirmed through device analysis.Possible causes are braid incorrectly sized to vessel, resistance, other indwelling endovascular stents, braid damaged, braid deployed in vessel bend, micro catheter tip not correctly placed, or braid not anchored correctly.The braid was found damaged.Potential causes for braid damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/resheathing braid against resistance, or damage du ring return shipping as the braid was returned outside of its protective dispenser coil and introducer sheath.There was no non-conformance to specifications identified that led to the reported issues.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.

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
• Type of Device: 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: 16328150
• MDR Text Key: 309145028
• Report Number: 2029214-2023-00213
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-450-20
• Device Catalogue Number: PED-450-20
• Device Lot Number: B343501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR