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

Model Number PED-475-30

Device Problem Break (1069)

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

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device involved in the event has not been returned; therefore the event cause could not be determined.Correspondence has been sent out for return of the device.Once the device has been received and investigation completed.A supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the medtronic flow diverter pushwire fractured.Prior to the event, the medtronic microcatheter was placed in the m1 segment of the middle cerebral artery (mca) and then the flow diverter was pushed in the cavernous sinus and large resistance was felt.The flow diverter was finally able to reach the m1 segment, but the pushwire could only be pushed to the tip of the microcatheter and could not be pushed out any further.The entire system (flow diverter and microcatheter ) were withdrawn to the internal carotid artery (ica) and that was when the physician noticed that the pushwire had fractured and the flow diverter braid remained in the microcatheter when the whole part was withdrawn.The physician decided to terminate the treatment.The patient was undergoing embolization treatment of a unruptured saccular aneurysm measuring 11.69mm x 6.35mm located in the ophthalmic segment of the left internal carotid artery (ica).The distal and proximal landing zone was 3.45mm x 4.48mm.The patient¿s vasculature was moderate in tortuosity.It was unknown if the patient was on dual antiplatelet therapy.There are no images for review.

Manufacturer Narrative

A4- patient information - weight = additional information h10.Additional manufacturer narrative - additional information, device evaluation the device will not be returned for investigation; however images were provided for review.In image the pipeline flex embolization device appears to be within the medtronic catheter.The pipeline flex pushwire appears to be protruding from within the catheter hub for an undeterminable length.What appears to be the pipeline flex tip coil is seen protruding from within the catheter distal tip.Based on the image provided the customer's reports of "pushwire break" could not be confirmed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9633376
• MDR Text Key: 186775841
• Report Number: 2029214-2020-00078
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2022
• Device Model Number: PED-475-30
• Device Lot Number: A844330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 52