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

Model Number 106524US

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

Patient Problems Dyspnea (1816); Hypoxia (1918); Pleural Effusion (2010); Pulmonary Edema (2020); Tachycardia (2095); Cough (4457)

Event Date 01/05/2022

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

The patient presented to the emergency center on (b)(6) 2022 with dyspnea where he was found to be hypoxic (89-91%) on room air which improved with 2l of nasal o2/ chest x-ray that showed mild pulmonary edema with small bilateral pleural effusions.Right > left edema with intermittent cough.The patient was admitted on (b)(6) 2022 and was given 2 mg intravenous bumex and had significant urine output.The patient was admitted to the floor for further management.On (b)(6) 2022 the patient stated his symptoms had significantly improved but he remained on 2l.The patient was also noted to have intermittent increase in pulsatility index (pi) events occurring in clusters (morning, afternoon, and late night).No changes were made to the device.Additional information stated that the subject had intermittent lab values where potassium was 3.3 during two consecutive days.The patient was reported to have non-sustained ventricular tachycardia with shortness of breath and cough.Basal metabolic labs showed mild hypokalemia on (b)(6) 2022.This was treated with oral potassium tablets that were likely caused by diuretic therapy.

Event Description

Additional information stated that outside labs were done on (b)(6) 2022 (sodium -131) and presentation labs on (b)(6) 2022 showed that the patient was hyponatremic.The patient's hypokalemia and nsvt both resolved on (b)(6) 2022.The patient was discharged on (b)(6) 2022.The patient was readmitted on (b)(6) 2022 with similar complaints and received ceftriaxone and doxycycline.The ceftriaxone was stopped but doxycycline continued for 5 days for bronchitis along with 5 days of 40 mg prednisone.Imaging suggests pleural atelectasis which was mildly increased on the right and left.Ultrasound thoracentesis was done on (b)(6) 2022 which removed 1500 cc of bloody fluid.Basal metabolic panel results showed that potassium had resolved (k = 3.9) prior to (b)(6) 2022 discharge but increased to k=4.0 a week later.Their dry cough was much improved, shortness of breath and chest pain were resolved.The patient was discharged on (b)(6) 2022.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported patient-related conditions and cardiac arrhythmia could not conclusively be determined through this evaluation.The patient remains ongoing on heartmate 3 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 specification.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of the ifu, ¿introduction¿, lists adverse events that may be associated with the use of heartmate 3 lvas, including cardiac arrhythmia.Section 4 of the ifu, ¿system monitor¿, explains that pulsatility index (pi) events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events are also referred to as pi events and may be initiated for reasons other than true pi events.Some reasons include sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.If the system detects a pi event, the pump speed automatically drops to the low speed limit and slowly ramps back up at a rate of (b)(4) to the fixed speed setpoint.There are no audible alarms with a pi event.Additionally, this section (under ¿optimal fixed speed¿) outlines how to determine the optimal fixed speed and low speed limit.Additionally, section 6 of the ifu, ¿patient care and management¿, lists arrhythmia as a potential late postimplant complication.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 (ASSISST) 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: 13346989
• MDR Text Key: 287543464
• Report Number: 2916596-2022-00252
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/06/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7975741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American