MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-500-25

Device Problem Break (1069)

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

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation. However, the device is pending return. Upon receipt of the device a supplemental report will be filed. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during embolization treatment of carotid artery, while pipeline flex device was advanced in the medtronic catheter the pipeline pushwire broke. It was reported that the physician felt strong resistance while delivering the pipeline through microcatheter after flushing as according to the ifu. However, the physician somehow kept delivering, deployed the flow diverter and started resheathing, but resheathing was not very smooth. The flow diverter was deployed and opened at the desired position. However, while advancing the microcatheter in order to retrieve the pipeline delivery pushwire, the catheter got caught on the delivery pusher (probably the sleeve of the system). The physician kept retrieving the pusher into the catheter but still the pushwire caught on the catheter. The physician successfully retrieved the pushwire into the catheter by pushing the pusher little bit. However, upon completing retrieving, snapping noise was heard. Nothing was left inside the patient¿s body. The vessel was slightly severe and slightly large in diameter. There were no reports of patient injury in association with this event.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 8150716
• MDR Text Key: 129912914
• Report Number: 2029214-2018-01048
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/09/2021
• Device Model Number: PED-500-25
• Device Lot Number: A643198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial