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

Model Number	PED2-450-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
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 three pipelines failed to open distally.The physician had attempted to deploy multiple devices, but the devices would not open distally despite multiple attempts of pushing the device, unsheathing the device, and combinations thereof.The middle of the pipelines had been positioned in a bend, and more than 50% had been deployed when the failed to open.The patient's had been resheathed more than 2 times.No additional steps were taken to open the device. the patient received stent-assisted coiling, and did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left ica.The max diameter and neck diameter were ~6mm.The patient's vessel tortuosity was severe.The landing zone was 10mm distal and 10mm proximal. dual antiplatelet treatment was administered.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): 3 pipeline flex embolization devices and 3 phenom-27 catheters were returned for analysis within a shipping box; within a sealed tyvek biohazard pouch; within a sealed biohazard pouch and within another sealed biohazard bag.Visual inspection/damage location details: no device malfunction was reported with the phenom-27 catheters.Due to the condition in which the pipeline flex devices and phenom-27 catheters were returned, it could not be determined which pli or product event each pipeline and phenom catheter corresponds to.(pipeline 1/phenom-27 1) no damages were found with the phenom hub; however, the pipeline pushwire was returned within the phenom catheter.The proximal end of pipeline pushwire was found extending ~45.2cm from phenom hub.The pipeline was then removed from the catheter for further analysis.No damages or irregularities were found with the phenom-27 hub.No flash or voids molded were observed with the hub.No damages or irregularities were found with the distal tip and marker band.The catheter total length was measured and found to be ~156.0cm (reference: 156.5cm) and the usable length was found to be ~149.4cm which is within specification (150cm ± 5cm).No bends or kinks were found with the pipeline pushwire.The hypotube and ptfe were found to be intact.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found to be in good condition.The tip coil was found to be damaged.Proximal braid end was found to be opened and frayed.Distal braid end was found to be opened and frayed.No other anomalies were found with the device.(pipeline 2/phenom-27 2) no damages were found with the phenom hub; however, the pipeline pushwire was returned within the phenom catheter.The proximal end of pipeline pushwire was found extending ~45.7cm from phenom hub.The pipeline was then removed from the catheter for further analysis.No damages or irregularities were found with the phenom-27 hub.No flash or voids molded were observed with the hub.The catheter body was found to be flattened at ~6.4cm for ~2.3cm and kinked at ~0.3cm from distal tip.No damages or irregularities were found with the distal tip and marker band.The catheter total length was measured and found to be ~158.9cm (reference: 156.5cm) and the usable length was found to be ~152.3cm which is within specification (150cm ± 5cm).Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was unable to be confirmed as both braid ends were found to be opened.It is likely the failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.The customer reported vessel tortuosity as severe.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: 14489597
• Report Number: 2029214-2022-00874
• Device Sequence Number: 4680662
• Product Code: OUT
• UDI-Device Identifier: 00763000284527
• UDI-Public: 00763000284527
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 08/16/2022

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: 01/06/2025
• Device Model Number: PED2-450-16
• Device Catalogue Number: PED2-450-16
• Device Lot Number: B319428
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 74 KG