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 Bacterial Infection (1735); Chest Pain (1776); Fatigue (1849); Pneumonia (2011); Sepsis (2067); Tachycardia (2095)

Event Date 06/17/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was not feeling well the afternoon of (b)(6) 2022 with complaints of fatigue and achiness.The patient rested and was doing well until they began experiencing severe pain in the left abdomen in addition to chest pain.A fever was also noted to be unrelieved by tylenol.The patient was brought to the emergency room and was found to be tachycardic on arrival.Driveline dressing was removed and revealed purulent drainage from the driveline exit site (dles).Complete blood count (cbc) showed leukocytosis with left shift.Hemoglobin and hematocrit were stable though lactate and serum creatinine (srcr) were elevated.2 liters of fluid were administered and the patient was started on antibiotics for sepsis protocol.Vital signs stabilized and chest pain resolved.The patient was in and out of atrial fibrillation at low rates though it was noted that the patient had a history of atrial fibrillation prior to implant.Cultures from the sputum, blood and dles were positive for staphylococcus aureus and beta hemolytic streptococcus group c.A computed tomography (ct) scan showed consolidation in the left lung base which was concerning for pneumonia though it could represent atelectasis related to small pleural effusion.As of on (b)(6) 2022 the patient had been discharged home with antibiotics.

Event Description

Additional information: antibiotics administered were vancomycin and piperacillin/tazobactam (zosyn).On (b)(6)2022, the patient was noted to have mildly worsened shortness of breath.On (b)(6) 2022, the patient required oxygen intermittently due to shortness of breath.On (b)(6) 2022, shortness of breath remained present with associated wheezing.

Manufacturer Narrative

Section a2: patient date of birth was inadvertently added in initial report and should have been removed due to patient privacy laws.Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), 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 implant kit was shipped on (b)(6) 2022.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The heartmate 3 lvas ifu, rev.C, and the heartmate 3 patient handbook, rev.D, are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events including cardiac arrhythmia, sepsis, and infection (local, driveline, and pump pocket), that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, lists arrhythmia and infection as potential late postimplant complications.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.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: 15029344
• MDR Text Key: 295984523
• Report Number: 2916596-2022-12014
• 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: Study,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8249298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White