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

Model Number PED-450-20

Device Problems Component or Accessory Incompatibility (2897); Material Deformation (2976); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the central part of the tip of the medtronic flow diverter was not visible during the procedure and it was suspected to be damaged.Prior to the event, the medtronic flow diverter was delivered after the medtronic microcatheter was in place and everything was normal before the medtronic flow diverter was opened.After the tip of the medtronic flow diverter was released for the first time, the central part of the tip was not visualized under radiography.The device was retrieved and deployed again, but the results were the same so the medtronic flow diverter was removed from the patient.The patient was undergoing embolization treatment of an unruptured amorphous aneurysm located in the ophthalmic segment of the left internal carotid artery (ica).The patient was on dual antiplatelet therapy (dapt).The distal and proximal landing zone was 3.4mm x 4.3mm.The vasculature was moderate in tortuosity.

• Brand Name: PIPELINE FLEX
• Type of Device: 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9528253
• MDR Text Key: 208421335
• Report Number: 2029214-2019-01305
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2022
• Device Model Number: PED-450-20
• Device Lot Number: A880367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• Date Device Manufactured: 08/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR