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

Catalog Number 106015

Device Problem Partial Blockage (1065)

Patient Problems Death (1802); Hemolysis (1886); Thrombus (2101)

Event Date 12/11/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Approximate age of device - 2 years and a month.(b)(4).The pump was not explanted and therefore will not be returned for evaluation.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) on (b)(6) 2015.The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2015.It was reported that the patient had fatigue, weakness, shortness of breath and the device had low flow alarms.The patient called 911 and was emergently transported to the hospital.On admission, the inr was 3.9, lactate dehydrogenase was 415 u/l and 469 u/l, plasma free hemoglobin of 20 mg/dl and 40 mg/dl.The patient was started on dobutamine in emergency room.Ramp echocardiogram revealed little change in the left ventricular size, and the aortic valve remain open despite speed changes.A cardiac ct angiogram showed an adherent thrombus in the outflow graft.The patient was switched from dobutamine to milrinone.Cardiothoracic surgery was consulted; however the patient was deemed not a surgical candidate for pump exchange or heart transplant.Hospice consult was offered but the patient and family refused.The patient was given integrilin and plavix initially with no effect.Tissue plasminogen activator bolus and infusion was also administered with no effect.The patient had to be intubated due to probable pulmonary edema.The patient expired on (b)(6) 2017 secondary to ventricular fibrillation and ventricular tachycardia arrest.

Manufacturer Narrative

A direct correlation between the left ventricular assist system (lvas) and the reported event could not conclusively be established through this evaluation.No log files were submitted for evaluation; the report of low flow alarms was not confirmed.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 no deviations from manufacturing or quality assurance 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: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7249732
• MDR Text Key: 99293177
• Report Number: 2916596-2018-00507
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 04/23/2018
• Supplement Dates FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 67