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

Model Number	PED2-450-25
Medical Device Problem Codes	Positioning Failure (1158); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
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 distal part of the pipeline failed to open.The patient was undergoing treatment for an unruptured, primarily saccular aneurysm with a fusiform neck component located in the right cavernous ica.The max diameter was 15.5mm, and the neck diameter was 6.5mm.The patient's vessel tortuosity was severe.The landing zone was 3.8mm distal and 4.2mm proximal.Dual antiplatelet treatment was administered, and the act value was 197.It was reported that difficulty was noted as the pipeline passed through the cervical segment due to the patient's anatomy.The distal part of the pipeline was observed to have lazy opening, and the physician questioned whether the stent was twisted as it appeared to show difficulty opening on the anterior x-ray.Angiographic imaging was unable to confirm twisting of the stent; however, due to the confirmation of lateral x-ray plane not showing a ribboning effect, a note was made that the anatomy was extremely tortuous and had multiple turns in multiple directions.It was noted that 3d imaging available could suggest a vascular anomaly that could have been causing the pipeline to appear as though it was not opening all the way.Two resheathing attempts and minor adjustments in the landing zone were made, but neither resolved the visualization of the pipeline.The physician decided to remove the pipeline, and a new device was successfully placed.It was noted that the distal end of the pipeline was placed in a bend, and no other steps were taken to open the device.More than 50% had been deployed when it failed to open. the patient did not experience any injury or complications.Angiographic results post procedure showed successful placement of the pipeline with no vascular abnormalities.The devices were flushed and prepared according to the instructions for use (ifu).Ancillary devices include a penumbra bmx sheath, phenom plus guide catheter, synchro 14 guidewire, phenom 27 microcatheter, axium frame coils, stryker xl coils, echelon 10 catheter, and stryker transform balloons.
Additional Manufacturer Narrative
H3: the distal end of the pipeline flex shield braid was not opened due to damaged braid.The proximal end of the braid appeared to be fully opened and moderately frayed.No other anomalies were observed.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: 12538362
• Report Number: 2029214-2021-01211
• Device Sequence Number: 19841509
• Product Code: OUT
• UDI-Device Identifier: 00763000284558
• UDI-Public: 00763000284558
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/08/2021

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: 04/20/2024
• Device Model Number: PED2-450-25
• Device Catalogue Number: PED2-450-25
• Device Lot Number: B193956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 54 KG