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

Model Number PED-500-18

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline pushwire broke off in the patient. The patient was undergoing surgery for treatment of a saccular, unruptured, cavernous right ica aneurysm with a max diameter of 9mm, a 5mm neck diameter, and a landing zone of 4. 8x5mm. It was noted the patient's vessel tortuosity was moderate. It was reported that the pipeline was deployed in the m1, and when the physician started to drag the device back, the pushwire broke off from the distal tip proximal to the re-sheathing marker. A snare was used to try and retrieve the wire, but it didn't work. Four atlas stents were placed to cover the wire from the pcom (posterior communicating artery) and into the cavernous section past the pipeline but before the aneurysm. It was indicated that all devices were prepared as per the instructions for use (ifu), and it was stated the patient was doing well. Ancillary devices include a 6fr shuttle sheath, phenom 027 microcatheter, phenom plus guide catheter, and a synchro 2 guidewire.

• 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: 9622387
• MDR Text Key: 188888745
• Report Number: 2029214-2020-00069
• 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,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2022
• Device Model Number: PED-500-18
• Device Catalogue Number: PED-500-18
• Device Lot Number: A808107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/23/2020 Patient Sequence Number: 1