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

Model Number 106524US

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

Patient Problems Fever (1858); Hematoma (1884); Intracranial Hemorrhage (1891); Vomiting (2144)

Event Date 11/09/2023

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 was diagnosed with an upper respiratory infection with initial symptoms of on and off headaches on (b)(6) 2023.The patient noted further sinus pain, fever, and nasal drainage on (b)(6) 2024 for a few weeks and was treated by a primary care physician (pcp).The patient was seen in the clinic on (b)(6) 2023 with improved symptoms.The patient's mother noted that the patient vomited, was not complete dressed, and was confused despite appearing normal an hour ago on (b)(6) 2023 and took them to the emergency department.The patient had acute subarachnoid hemorrhage (sah) and subdural hematoma (sdh), despite no previous concerns for stroke.It was unknown if the sah and sdh were caused by a fall.The patient's international normalized ratio was supratherapeutic at 4.2 and reversed.A computed tomography was performed, and rapid neurological decline was noted after it.The patient's glasgow coma scale (gcs) dropped from 13 to 6.A hemicraniectomy was performed, and the patient was given mannitol and hypertonic saline.However, the patient had significant cerebral edema with brain herniation, midline shift and brain stem compression.The patient was ultimately extubated, and the pump was deactivated.The patient passed away due to intracranial hemorrhage (ich) and sah.The outcome was not device related.The device operated as intended.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6) and the reported events could not be conclusively established through this evaluation.It was communicated that the device will not be returned for evaluation.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 left ventricular assist system (lvas) instructions for use (ifu) rev.C and the heartmate 3 patient handbook rev.D are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events that may be associated with the use of the heartmate 3 lvas, including bleeding, infection, other neurological events (not stroke-related), and death.Additionally, several sections of the ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.Section 6 of the ifu, ¿patient care and management¿, lists infection as a potential late postimplant complication.This section also provides information regarding anticoagulation, including the recommended inr (international normalized ratio) values.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18947024
• MDR Text Key: 338183704
• Report Number: 2916596-2024-01642
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 8633163
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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): Death
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Race: White