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

Model Number 106524US

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

Patient Problems Hypoxia (1918); Vomiting (2144); Respiratory Failure (2484)

Event Date 06/14/2022

Event Type  Death  

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 passed away due to acute hypoxic respiratory failure.The cause of the respiratory failure was noted to be hypoxia after bronch with difficult et tube exchange as well as vomiting with aspiration of tube feeds.The patient exhibited increased oxygen requirements, elevated lactic, low flows, and multiple code events.The patient was treated with max pressors, continuous renal replacement therapy (crrt), and extracorporeal membrane oxygenation (ecmo).The patient's outcome was not device or therapy related, or related to the left ventricular assist device (lvad) implant procedure.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between the device and the reported event could not be confirmed.Review of the submitted log files noted an active low flow alarm at 17:05 on 11jun2022 of the controller periodic log file.Multiple changes to the set speed were made in the hours following the alarm.There were no atypical events or alarms captured in the controller event log file.The log files appeared to show the system operating as intended.An autopsy was not performed and no product was returned for evaluation.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate 3 lvas ifu lists respiratory failure, renal dysfunction, and death as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.The introduction section discusses pump speed, power, flow, and pi.The system monitor explains that the low flow hazard alarm is triggered when flow is less than 2.5 lpm and explains that changes in patient condition can result in low flow.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) 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14982500
• MDR Text Key: 295671192
• Report Number: 2916596-2022-11873
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8434714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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; Death; Life Threatening
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 163 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American