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

Model Number 106015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Intracranial Hemorrhage (1891)

Event Date 12/10/2018

Event Type  Death  

Manufacturer Narrative

Approximate age of device -1 year, 9 months.Manufacturer's investigation conclusion: a full evaluation of the device could not be conducted as the device was not returned.A correlation between the device and the reported event could not be conclusively determined.The instructions for use list stroke and bleeding as a potential adverse events that may be associated with the use of heartmate ii left ventricular assist system.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the patient expired due to withdraw of care after a large right sided ich (intracranial hemorrhage).The device was working properly and will not be returned.No additional information was provided.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• 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: 8205750
• MDR Text Key: 131694885
• Report Number: 2916596-2018-05640
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5931479
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• 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
• Patient Age: 73 YR
• Patient Weight: 164