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

Model Number 106015

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

Patient Problems Syncope/Fainting (4411); Gastrointestinal Hemorrhage (4476)

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported that the patient presented with gastrointestinal bleeding and had low flow alarms on the evening of (b)(6) 2024.Syncope was observed at the time of the low flow alarms.An esophagogastroduodenoscopy was performed and found to be unremarkable.The patient's hemoglobin levels were 5.3.The patient received a blood transfusion; the patient was given volume and the alarms resolved.A review of the log files revealed 2 low flow events on 05mar2024.There were no other unusual events recorded in the log file event history.The plan of care was to discharge the patient home.

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: a direct correlation between the heartmate ii left ventricular assist system (lvas), serial number (b)(6) and the reported events could not be conclusively established through this evaluation.Review of the submitted log file confirmed low flow events; however, a specific cause for these events could not be conclusively determined.The submitted log file captured two transient low flow hazard events on 05mar2024.There were no other notable alarms captured.The pump appeared to function as intended at the fixed speed throughout the duration of the file.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate ii lvas, serial number (b)(6) with no further related issues reported at this time.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.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including bleeding, that may be associated with the use of the heartmate ii lvas.Section 6 ¿patient care and management¿ contains information regarding the recommended anticoagulation therapy and inr (international normalized ratio) range, as well as considerations for when there is a risk of bleeding.Section 1 of the ifu also provides an explanation of pump parameters, including flow.This section explains that pump flow is a calculated value that is estimated based on pump power.Section 4 of the ifu, ¿system monitor¿, provides information about the pump flow display and the low flow hazard alarm condition.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm and explains that changes in patient conditions can result in low flow.Section 7 of the ifu, ¿alarms and troubleshooting¿, and section 5 of the patient handbook, ¿alarms and troubleshooting¿, outline hazard and advisory alarms, including the low flow hazard alarm, and provides information regarding how to respond to and troubleshoot the alarms.Furthermore, the patient handbook contains a section on handling emergencies.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• 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: 18980829
• MDR Text Key: 338626719
• Report Number: 2916596-2024-01502
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: 106015
• Device Lot Number: 5862137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2017
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 112 KG