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

Model Number	PED-425-30
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer provided image of the pipeline flex braid.In the images provided, both ends of the pipeline flex braid appear to be fully open.The images of the pipeline flex show a detached braid from the push wire, the distal and proximal ends of the braid were unable to be identified.Based on the image provided, the report of "failure to open" could not be confirmed.Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the pipeline flex distal section did not open.Upon removal of the devices, the tip of the marksman catheter was noted to be damaged and kinked.This event occurred in the internal carotid artery (ica).The ica aneurysm was unruptured, and amorphous.The max diameter was 4.5 mm and the neck was 4.5 mm.The distal landing zone was 3.5 mm and the proximal was 4.5 mm.The vessel anatomy was moderate in tortuosity.The pipeline and the accessory devices were prepared as indicated in the instructions for use (ifu).No patient injury occurred.Post the intervention, the angiographic results were good.A new pipeline device was used to treat the patient.

• 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: 9788566
• Report Number: 2029214-2020-00194
• Device Sequence Number: 14025585
• Product Code: OUT
• UDI-Device Identifier: 00847536016262
• UDI-Public: 00847536016262
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: 03/17/2022
• Device Model Number: PED-425-30
• Device Lot Number: A800199
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR