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

Model Number	PED2-500-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
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 3 pipelines failed to open.The patient was undergoing surgery for an "aneurysm treated with fred." it was a ruptured aneurysm within the left internal carotid artery, in a blister.It was noted the patient's vessel tortuosity was severe.  it was reported that they could not get the distal end of all devices opened, tried three different devices.The devices were not placed in a bend.Less than 50% of the pipeline had been deployed when it failed to open.The pipelines were resheathed "less than or equal to 2 times." there were no additional steps or other devices required to open the pipelines.The pipelines were used for an indication that is not approved (off-label), in a ruptured blister.The pipeline and any accessory devices were prepared as indicated in the ifu.The devices were resheathed and removed from the patient with the microcatheter.No patient symptoms or further complications were reported as a result of this event.

• 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: 12899586
• Report Number: 2029214-2021-01537
• Device Sequence Number: 4918044
• Product Code: OUT
• UDI-Device Identifier: 00763000284749
• UDI-Public: 00763000284749
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Report Date (Section B): 11/30/2021

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: 08/03/2024
• Device Model Number: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: B245068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 11/30/2021
• Date Device Manufactured: 08/04/2021
• 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 Sex: Unknown