MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) DEVICE

Model Number 106524US

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

Patient Problems Muscle Weakness (1967); Unspecified Kidney or Urinary Problem (4503)

Event Date 06/10/2023

Event Type  Injury  

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the patient developed leg weakness and increased creatinine on (b)(6) 2023.The patient was hospitalized for conservative care.

Event Description

Additional information reported that the patient's weakness was due to low consumption of food and due to angiotensin receptor blockers (arb) related creatinine increase.The patient's creatinine levels were 2.16 mg/dl.The issue resolved and was not considered to have been device related.The patient was discharged.It was noted that the patient did not have any renal dysfunction prior to their pump implant.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively determined through this evaluation.The patient remains ongoing on hm3 lvas, serial number (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu), is currently available.This ifu lists potential adverse events, including renal dysfunction, that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) DEVICE
• 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: 18741319
• MDR Text Key: 335777336
• Report Number: 2916596-2024-00906
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524US
• Device Lot Number: 8717138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 60 KG