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

Model Number PED-400-20

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex pushwire was returned for evaluation. There was no pipeline flex braid returned with the pushwire. The pipeline flex pushwire was found outside of the phenom 27 catheter. The pipeline flex pushwire appeared to be detached at the hypotube proximal to the wire weld. No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper. The ends of the detached pushwire were sent out for sem/eds analysis. Based on the analysis findings and sem/eds analyses, the pipeline flex was confirmed to have "pushwire detached at hypotube proximal to the wire weld". A review of the manufacturing process and lot history record did not uncover any deficiencies. In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the pipeline flex distal tip of the delivery system separated. The device separation occurred after deployment of the device and during recapture of the delivery wire. The separation occurred within the catheter. The device tip and the devilry system will be returned for analysis. There was no patient impact as a result of this event. The vessel anatomy was moderate. This event occurred in the left vertebral. A continuous flushed was used during the case. The devices were prepared and used per the instructions for use (ifu). Resistance was felt when the delivery wire was retrieved.

• 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
• 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: 9836907
• MDR Text Key: 184451570
• Report Number: 2029214-2020-00236
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED-400-20
• Device Catalogue Number: PED-400-20
• Device Lot Number: A837027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial