MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; Ventricular (assist) bypass

Model Number 106524US

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930)

Event Date 04/10/2024

Event Type  Injury  

Event Description

It was reported that the patient was admitted on (b)(6) 2024 due to abdominal pain and infection.The patient was reported to have low flow alarms.A positron emission tomography (pet) scan was performed that revealed an incidental finding of outflow graft obstruction.The patient was transferred to another hospital on (b)(6) 2024 for further workup.The event log file contained low flow estimates as well as low flow hazard events on (b)(6) 2024 between 10:09am-11:20am.These events occurred when the calculated pulsatility index (pi) was elevated.No additional low flows were recorded since.

Manufacturer Narrative

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

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 19215988
• MDR Text Key: 341423605
• Report Number: 2916596-2024-02409
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: (01)00813024013297(10)7214357(17)220121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/21/2022
• Device Model Number: 106524US
• Device Lot Number: 7214357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2019
• 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): Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 106 KG