MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2024

Event Type  Death  

Event Description

It was reported that the patient passed away due to respiratory failure.The patient had a known outflow graft thrombus and was not considered a pump exchange candidate due to their significant right ventricular failure and chronic obstructive pulmonary disease.The patient made the decision to move towards palliation and had their pump turned off on the evening of (b)(6) 2024.The outcome was not thought to be device or therapy-related.It was unknown if an autopsy would be performed.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: no device-related issues with (b)(6) were reported or identified through this evaluation.It was noted that the device would not return for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) rev.C, and the heartmate ii lvas patient handbook rev.C are currently available.No device-related issues were reported; however, section 1 of the ifu, ¿introduction¿, lists potential adverse events that may be associated with the use of the heartmate ii lvas.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had chronically elevated lactate dehydrogenase (ldh) since (b)(6) 2023, but no thrombus was found.The patient was admitted for workup and their international normalized ratio was adjusted during their admission, but demanded leaving the hospital before workup was completed.The patient was not considered a pump exchange candidate due to their significant pre-existing right ventricular failure and chronic obstructive pulmonary disease.They made the decision to move towards palliation and had their pump turned off on the evening of (b)(6) 2024.The patient passed away due to respiratory failure.The outcome was not thought to be device or therapy related.It was unknown elevated ldh was the cause of the patient outcome.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19216536
• MDR Text Key: 341428312
• Report Number: 2916596-2024-02441
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: (01)00813024011224(10)
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2014
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 54 KG