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

Model Number	PED-475-25
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
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 in the process of using the pipeline embolization device (ped), the tip opened well, but the middle section was kinked.After repeated operations, the surgeon still could not opened the stent.The ped was not positioned in a bend when it failed to open, more than 50% had been deployed, resheathing was performed less than three times, and no additional steps or other devices were used in an attempt to open the stent.The device was withdrawn from the body, and it was found the stent was still in a kinked state and could not be opened.The marksman microcatheter also had a certain accordion damage in the distal segment.Replacement devices were used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results were normal.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left ophthalmic artery segment with a max diameter of 3.2 mm and a 2.5 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 42.Ancillary devices include an 8f sheath, 8f guiding catheter.
Event or Problem Description
Additional information received indicated a continuous flush had been used during the procedure, and there was resistance during the delivery of the pipeline.
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.Product analysis findings: the pipeline flex was returned stuck within the distal segment of the marksman catheter; within the inner pouch; inside of a sealed bio-hazard bag and a shipping box.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.Bends were found at 19.0cm to 35.0cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The pipeline flex was pushed out from the catheter with difficulty.The catheter was flushed with water and found patient.No other anomalies was observed.Based on the returned devices, the pipeline flex was confirmed to have ¿resistance during delivery¿ as the returned pipeline flex was found stuck inside the distal segment of the marksman catheter.Regarding to the "failure to open at the middle section", the customer complaint could not be confirmed as the returned pipeline flex was fully opened and frayed at both ends.The damage to the braid on the ends of the pipeline flex braid is likely the results of the physician re-sheathing the device more than recommended two times.From the damages seen on the catheter (accordioning), pusher (bending), pipeline flex braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex through the marksman catheter against the resistance.However, the root cause could not be determined.Possible causes of the resistance during delivery include patient's vessel tortuosity and lack of continuous flush with heparinized saline during procedure.There was no non-conformance to specifications identified that led to the resistance issue.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw t he catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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
• MDR Report Key: 11574545
• Report Number: 2029214-2021-00347
• Device Sequence Number: 14541045
• Product Code: OUT
• UDI-Device Identifier: 00847536016774
• UDI-Public: 00847536016774
• 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): 06/29/2021

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: 08/08/2023
• Device Model Number: PED-475-25
• Device Catalogue Number: PED-475-25
• Device Lot Number: B066910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 03/29/2021; 06/13/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/20/2021; 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 50