MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106015

Device Problems Pumping Stopped (1503); Use of Device Problem (1670); Cut In Material (2454)

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

Event Date 11/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 5 months.The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient called to report he had nicked his driveline.The patient experienced red heart and driveline disconnected alarms.The pump running symbol on the patient's system controller was off and the displayed pump speed was zero.On (b)(6) 2015, the patient's pump was exchanged due to the severed driveline and the patient was discharged on (b)(6) 2015.

Manufacturer Narrative

It was reported that he device would not be returned for evaluation.Device evaluation: the reported pump stop and alarms were confirmed based on the information contained in the log file retrieved from the returned system controller.It was reported that the patient had a pump exchange on (b)(6) 2015 and was discharged to home on (b)(6) 2015.The patient remains on vad support with the replacement device.The explanted device was not returned for evaluation.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

Event Description

Additional information: it was reported that the patient had nicked the driveline with scissors and caused the pump to stop.The patient was not symptomatic upon arrival at the emergency room.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5358492
• MDR Text Key: 35606511
• Report Number: 2916596-2016-00075
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 119