MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT

Model Number PED2-425-20

Device Problems Break (1069); Activation Failure (3270)

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

Event Date 01/29/2020

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 could not be opened in the middle third segment despite pulling, pushing, and resheathing maneuvers. They attempted to remove the flow diverter, but it was stuck inside the medtronic microcatheter so both the flow diverter and microcatheter were replaced with new devices to successfully complete the procedure. No patient injury was reported as a result of the event. The patient was undergoing embolization treatment of a unruptured saccular aneurysm measuring 17mm with unknown neck size located in the paraclinoid/ophthalmic segment of the left internal carotid artery (ica). The distal and proximal landing zone diameters were unknown. The patient¿s vasculature was severe in tortuosity. The patient was on dual antiplatelet therapy, but pru levels were unknown. Post procedural angiography was satisfactory. The devices were prepared as indicated in the instructions for use (ifu).

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 9685691
• MDR Text Key: 198870685
• Report Number: 2029214-2020-00124
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/06/2021
• Device Model Number: PED2-425-20
• Device Catalogue Number: PED2-425-20
• Device Lot Number: A736446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial