MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU

Model Number 106016

Device Problems Partial Blockage (1065); Infusion or Flow Problem (2964)

Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Thrombus (2101)

Event Date 07/14/2018

Event Type  Death  

Manufacturer Narrative

Approximate age of device ¿ 1 year and 9 months the device is expected to be returned for analysis.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 was admitted to the hospital on (b)(6) 2018 due to extensive intracerebral bleeding.In order to perform a needed operation at that time, anticoagulation therapy was abandoned.What followed next was reportedly no flow through the pump, indicating a suspicion of pump thrombosis.The pump was stopped on (b)(6) 2018, and the patient subsequently expired on (b)(6) 2018.No additional information was provided.

Manufacturer Narrative

No product was returned for evaluation.A correlation between the device and the reported event could not be conclusively determined.Device thrombosis, stroke, bleeding, and death are listed in the instructions for use as potential adverse events that may be associated with use of the heartmate ii left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: it was reported by the healthcare professionals that the cause of death was not related to the pump; therefore, the pump would not be returned for evaluation.No additional information was provided.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, EU
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7864303
• MDR Text Key: 119819668
• Report Number: 2916596-2018-03786
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 106016
• Device Catalogue Number: 106016
• Device Lot Number: 5485974
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention