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

Model Number 104911

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); Hemorrhage/Bleeding (1888); Dizziness (2194); Hematuria (2558); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had pump thrombosis.The patient presented with a lactate dehydrogenase level of 1575, plasma-free hemoglobin of 51, hematuria, elevated asparte transpherase, and acute kidney injury.The patient's only symptom other than hematuria was dizziness.An echocardiogram on (b)(6) 2024 showed no evidence of obstruction to the inflow cannula.The outflow cannula was not well visualized.They had a left ventricle end-diastolic diameter of 5cm, and their aortic valve was closed.No power spikes were seen, but pulsatility index events with speeds drops and a harsh murmur were noted.The patient had a heartmate ii to heartmate 3 pump exchange on (b)(6) 2024.

• 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: 18923326
• MDR Text Key: 337894562
• Report Number: 2916596-2024-01383
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: 00813024011170
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 104911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 106 KG