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

Model Number 106524US

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

Patient Problems Atrial Fibrillation (1729); Hypoxia (1918); Septic Shock (2068); Respiratory Failure (2484); Hemorrhagic Stroke (4417); Ischemia Stroke (4418); Embolism/Embolus (4438); Gastrointestinal Hemorrhage (4476)

Event Date 12/30/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient's postoperative course was complicated by acute hypoxic respiratory failure requiring reintubation on (b)(6) 2022; tracheostomy placement on (b)(6) 2022; atrial fibrillation with rapid ventricular response (afrvr) and ventricular tachycardia (vt) requiring a lidocaine infusion (transitioned from mexiletine); right middle cerebral artery (r mca) infarction suspected to be embolic; septic shock determined by bilateral bronchoalveolar lavage (bal) on (b)(6) 2022 and blood cultures on (b)(6) 2022 revealing candida glabrata); gastrointestinal bleeding (gib) requiring multiple blood transfusions and vasopressor support; and altered mental status (ams) secondary to r mca infarct, sepsis, and metabolic derangements.The patient continued to decline despite maximum support.On (b)(6) 2022 the patient was transitioned to comfort care and passed peacefully at 13:02.

Manufacturer Narrative

Manufacturer's investigation conclusion.A specific cause for the reported events and subsequent patient outcome could not be conclusively determined.In addition, a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6) , and the reported event could not be conclusively established.The device will not be returned for evaluation.No product is available for investigation.The current heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu), rev.C, lists respiratory failure, cardiac arrhythmia, stroke, gastrointestinal bleeding, and sepsis as adverse events that may be associated with the use of the hm3 lvas.Care instructions in reference to preventing infection are provided throughout this ifu, including sections titled "caring for the driveline exit site" and "controlling infection." this document also provides information regarding anticoagulation, including recommended inr values, and the suggested anticoagulation modifications in the event that there is a risk of bleeding.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The mod cable shipped on 22dec2021.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: 14429891
• MDR Text Key: 291941760
• Report Number: 2916596-2022-10766
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8233838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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): Death
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White