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

Model Number 106015

Device Problems Device Stops Intermittently (1599); Cut In Material (2454); Infusion or Flow Problem (2964)

Patient Problems Hemolysis (1886); Thrombus (2101)

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

The lvad exchange referenced in this section was reported under mfr.Medwatch report # 2916596-2016-01756.(b)(4).Approximate age of device ¿ 5 months.The pump remains in situ, with the pump off and no longer supporting the patient.A supplemental report will be submitted when the investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that on (b)(6) 2017, the clinician observed elevated pump power and estimated flow readings in the system controller history file.The system controller log files were submitted and reviewed by the manufacturer¿s technical services representative, and pump stoppage events were observed.It was reported that the patient remained asymptomatic during the events.The patient was admitted with a lactate dehydrogenase (ldh) level elevated of 1062 u/l.The patient was treated with angiomax and primacor infusions.On (b)(6) 2017, the patient¿s pump was turned off due to multiple pump stoppage events.The patient was also listed 1a status for a heart transplant.As of (b)(6) 2017, the patient remained on the transplant list with device support turned off.

Manufacturer Narrative

No product was returned for evaluation.A direct correlation between the device and the reported event could not conclusively be established.A review of the submitted log files confirmed a significant increase in pump power over time, as well as elevated flow values and nearly constant pi events.Additionally, pump stoppages were captured on (b)(6) 2017 at 12:11 while the patient was supported by battery power, and at 21:49 while the patient was supported by the power module.Although the pump ramped back up to its set speed following these events, power remained elevated over 20 watts and continued to trend upward.Based on past experience with the heartmate ii lvas and similar reported events, this data could be indicative of potential device thrombosis; however, a specific cause for these events could not conclusively be determined through this evaluation.Thrombus and hemolysis are listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• 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: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6331370
• MDR Text Key: 67443007
• Report Number: 2916596-2017-00320
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 106015
• 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: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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: 50 YR
• Patient Weight: 94