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

Model Number	PED-500-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline distal and proximal ends failed to open.The device was prepared as indicated in the ifu and was not used off-label.The middle section of the pipeline was positioned in a bend.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed more than 2 times.There were no further steps taken to open the pipeline.The pipeline was removed with the microcatheter from the patient.There were no patient symptoms or complications associated with the event.A dapt (dual antiplatelet treatment) was administered and the pru level was 67.The angiographic result post procedure showed stagnation in the aneurysm and the parent vessel open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right cavernous with a max diameter of 11mm and a 5mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Ancillary devices include: neuron max sheath, phenom plus guide catheter, and a phenom 27 150cm microcatheter.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 12866487
• Report Number: 2029214-2021-01520
• Device Sequence Number: 5748600
• Product Code: OUT
• UDI-Device Identifier: 00847536019782
• UDI-Public: 00847536019782
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 08/05/2022
• Device Model Number: PED-500-30
• Device Catalogue Number: PED-500-30
• Device Lot Number: A877523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/23/2021
• Date Device Manufactured: 08/06/2019
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 74 KG