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

Model Number PED-375-20

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as the customer refuses to return it.Correspondence has been sent out for additional information to help with the investigation.Once the information as been received and the 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 medtronic flow diverter¿s proximal marker of the pushwire was broken.Prior to the event, the flow diverter was released and implanted in the intended location.The medtronic microcatheter was then prepared to retrieve the delivery system through the implanted flow diverter.When the flow diverter¿s protective sheath entered the microcatheter, the surgeon continued to pull the pushwire back.The distal development showed the distal coil did not move.It was suspected that that delivery system was broken.The medtronic microcatheter and delivery pushwire were removed from the patient as a whole.After removal from the body, the proximal marker of the delivery system was observed to be broken.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of a ruptured saccular aneurysm measuring 15.9m x 6.7mm located in the left cavernous sinus segment.The distal and proximal landing zone was 3.2mm x 3.9mm.The vasculature was minimal in tortuosity.The patient was on dual antiplatelet therapy.Post procedural angiography showed contrast agent retention.Ancillary devices: weixin co.20-50, 18-40, 16-40 coils, synchro14 guidewire, echelon 10 and marksman microcatheter, 6f navien guide catheter, unknown sheath.

• 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: 9547375
• MDR Text Key: 189192939
• Report Number: 2029214-2020-00004
• 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: 01/03/2020

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: 07/05/2022
• Device Model Number: PED-375-20
• Device Lot Number: A859763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/03/2020
• Date Device Manufactured: 07/06/2019
• 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: 58 YR