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

Model Number	PED2-500-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
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
Medtronic received a report that the distal end of the pipeline didn't open distally at first, but after some additional wagging and pushing, the pipeline opened at the distal end.The pipeline was then positioned in the target which was the terminal internal carotid artery (ica).The pipeline was pushed out of the phenom microcatheter and the pipeline didn't open proximally.The delivery wire was manipulated back and forth to get it to open but it didn¿t' work.The phenom microcatheter was used to bump with the pipeline and it still didn't open.These maneuvers took 30-40 minutes and could not get the pipeline to open proximally.The pipeline was withdrawn with the phenom microcatheter.The patient had a thrombus post pipeline removal.The pipeline was positioned in a bend at the proximal end.The pipeline was more than 50% deployed when it failed to open.The pipeline was resheathed less than or equal to two times.The pipeline was not used for an off-label use.The pipeline and any accessories were prepared as indicated in the instructions for use (ifu).  the patient was undergoing surgery for treatment of a saccular, unruptured left clinoid aneurysm with a max diameter of 6mm and a 4mm neck diameter.The landing zone artery size measurements were 3mm distally and 4.9mm proximally.The access vessel was the femoral artery with a diameter of 6mm.It was noted the patient's vessel tortuosity was moderate.  ancillary devices include a penumbra bmx sheath, phenom 027 microcatheter, sl 10 coil microcatheter, syncro 2 guidewire, and tetra 4 x8 coils were implanted prior to the pipeline procedure.
Additional Manufacturer Narrative
Product analysis#: (b)(4): equipment used: video inspection system (m-78210), ruler (m-83361) as found condition: the pipeline flex shield embolization device was returned for analysis within a shipping box; and within a plastic bio-pouch.Damage location details: no bend was observed on the pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the proximal bumper, re-sheathing pad, re-sheathing marker, distal marker.However, the tip coil was found to be damaged.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.One of the ends of pipeline flex shield braid appeared to be not fully opened due to damaged braid.The other end of the pipeline flex shield braid was found fully opened and moderately frayed.No other anomalies were observed.Testing/analysis: n/a, conclusion: based on the analysis findings, the pipeline flex shield could not be confirmed to have failure/incomplete open distal (flex) as the device was resheated.In addition, the proximal and distal ends could not be identified.The braid was found damaged.However, the root cause for damage could not be determined.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.

• 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: 17886958
• Report Number: 2029214-2023-01969
• Device Sequence Number: 7551827
• Product Code: OUT
• UDI-Device Identifier: 00763000284688
• UDI-Public: 00763000284688
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2025
• Device Model Number: PED2-500-12
• Device Catalogue Number: PED2-500-12
• Device Lot Number: B481484
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 100 KG