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

Model Number	PED-450-18
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2020
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 information regarding a pipeline flex device that failed to deploy at the distal end after there was resistance in a marksman catheter.The patient was being treated for an unruptured saccular aneurysm of the left supraclinoid ica.The aneurysm max diameter was 15.82mm with a neck diameter of 10.05mm.Vessel tortuosity was minimal.It was reported that there was some resistance of the pipeline in the microcatheter.The pipeline was slowly deployed but failed to open at the distal end.The pipeline was removed from the patient and was replaced successfully with a competitor's product.The patient did not sustain any harm or injury during the procedure.

• 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
• MDR Report Key: 9977534
• Report Number: 2029214-2020-00374
• Device Sequence Number: 2248159
• Product Code: OUT
• UDI-Device Identifier: 00847536016446
• UDI-Public: 00847536016446
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2020

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: 09/17/2022
• Device Model Number: PED-450-18
• Device Catalogue Number: PED-450-18
• Device Lot Number: A900253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR