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

Model Number	PED-450-25
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
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 failed to open in the middle section and was damaged.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ophthalmic artery segment.The max di ameter was 7mm, and the neck diameter was 6mm.The patient's vessel tortuosity was severe.The landing zone was 4mm distal and 4.5mm proximal.The access vessel was the femoral artery.It was reported that after the microcatheter was in place and the doctor started to deliver the pipeline it was found that the stent was kinked at the horizontal section of c4, and the anterior and posterior sites could be opened.The kink and flattened horizontal section of the stent could not be resolved by pushing and pulling the stent several times.The pipeline was repeatedly retrieved and repositioned to the distal side.After more than two resheathing attempts, it was still kinked at the c4 horizontal segment and could not be deployed normally.It was noted that there were burrs on the tip of the pipeline, so the entire pipeline and microcatheter delivery system were withdrawn.The pipeline was not positioned in a bend when the middle section failed to open, and more than 50% had been deployed at the time.After the whole set was withdrawn from the body, the assistant pulled the pipeline pushwire from the proximal end of the microcatheter so that the pipeline and developing wire at the distal end of the pushwire remained in the micro catheter.In order to remove the stent, the distal end of the microcatheter was cut, but the device was not found.Posterior fluoroscopy revealed that the stent was located in the proximal hub section of the microcatheter.The hub section of the microcatheter was removed to take out the pipeline, and the distal end of the stent was found to be rough.The device was replaced.And the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a phenom 27 microcatheter.
Additional Manufacturer Narrative
H3: based on the analysis findings, the pipeline flex was not confirmed to have failure to open at middle.The pipeline flex braid were found fully opened and moderately frayed.In addition, the middle section of the braid was found fully opened and no damage.However, the pipeline flex device was confirmed to have pushwire break/ separation.The pushwire was found to be separated proximal to the dps sleeves.Per the sem result features observed indicate the wire failed via torsional overload failure mechanism.It is likely that the patient tortuous anatomy may have contributed to this event.There was no non-conformance to specifications identified that led to the reported issue.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
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
Additional information was received.During the retrieval process of the whole system, the push wire was not detached.After the push rod and the micro catheter were all withdrawn together, it detached when pulling the push wire from the proximal end of phenom27 microcatheter in vitro, and the stent remained at the hub of phenom27 proximal end.There was friction/resistance, but not very high resistance.

• 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: 12313350
• Report Number: 2029214-2021-01011
• Device Sequence Number: 14620796
• Product Code: OUT
• UDI-Device Identifier: 00847536016507
• UDI-Public: 00847536016507
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2021

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: 08/28/2023
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: B077662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/13/2021; 10/29/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/10/2021; 11/16/2021
• Date Device Manufactured: 08/28/2020
• 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: Female