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

Model Number PED-425-20

Device Problem Break (1069)

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

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

As the device was received in a condition was contradictory to the complaint description.As received, the pushwire was found detached at the distal hypotube.The re-sheathing pad was found separate from the pushwire.This condition was not reported initially.In addition, pipeline flex pushwire was inadvertently cut during analysis.The tip coil was found bent.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The re-sheathing marker and proximal bumper were not found.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bends were found on the pushwire.The ends of the detached pushwire were sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.Based on the device analysis, the distal wire possibly detached due to tensile failure.However, the cause of the event could not be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the pipeline flex could not be pushed out from marksman.Tried a few times but still failed.Replaced with a new set and the patient was treated.The vessel anatomy was moderate in tortuosity.The aneurysm was in the cavernous sinus.The morphology was saccular.The max diameter of 7.88mm with a neck width of 6.78mm.The distal landing zone was 3.8mm and the proximal was 4.12mm.No patient injury occurred.Evaluation of the returned device found that the pushwire was found detached at the distal hypotube.The re-sheathing pad was found separate from the pushwire.

• 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: 9348880
• MDR Text Key: 186752831
• Report Number: 2029214-2019-01146
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Model Number: PED-425-20
• Device Lot Number: A822945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2019
• 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: 65 YR