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 Fall (1848); Pneumonia (2011); Ventricular Fibrillation (2130); Cardiogenic Shock (2262); Presyncope (4410); Heart Failure/Congestive Heart Failure (4446)

Event Date 07/02/2022

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the intensive care unit (icu) with cardiogenic shock post cardiac surgery.The patient required rapid increase in left ventricular assist device (lvad) speed with increase in vasopressors and inotropes due to a dilated right ventricle and signs of hypo-perfusion.The patient was also thought to have some post operative vasoplegia which resolved with gentle fluid resuscitation and vasopressors.The patient was weaned off of inotropic support when able.On (b)(6) 2022 the patient began complaining of a dry, nonproductive cough.Chest x-ray noted basilar atelectasis but no large effusion.The patient was prescribed mucinex (guaifenesin) twice daily and zyrtec (cetirizine) as needed.The patient was encouraged to get pulmonary toileting and getting up to chair with meals.Additional information stated that the reported issues resolved by increasing lvad speed, gentle fluid resuscitation, and removing vasopressors and inotropes.Additionally, it was stated that right heart failure existed prior to implant.

Manufacturer Narrative

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

Event Description

Chest x-ray revealed a possible left basal lung infiltrate.The patient was afebrile and without leukocytosis.They were conservatively managed with a low threshold for antibiotics if the status were to change.The patient endorsed vocal changes, ear, nose, and throat (ent) was consulted and performed a flexible fiberoptic laryngoscopy which revealed mild erythema of the arytenoids and bilateral vocal cord irritation.This was attributed to intubation and was expected to improve with time.On (b)(6) 2022 the patient reported subjective chills, fevers, and rigors with a worsening cough.There were concerns for possible infection, which was most likely hospital acquired pneumonia.Broad spectrum antibiotic therapy was initiated and infectious disease was consulted.Blood cultures and urinalysis were negative.White blood cell count was up trending prior to starting antibiotics but still within normal limits.The patient received vancomycin and zosyn for 5 days.Vancomycin was to be discontinued if methicillin-resistant staphylococcus aureus (mrsa) swab was negative.Later on (b)(6) 2022 the patient was ambulating to the bathroom when he developed a pre-syncopal event and fell to the floor.When the patient was helped back into bed he experienced an implantable cardioverter defibrillator (icd) shock and a low flow alarm.The patient had hit their head during the fall.Computed tomography (ct) scan of the head was negative for an acute bleed.The patient believed overwhelming fatigue contributed to his fall.The patient was disconnected from the telemetry monitor at the time of the fall.Icd interrogation revealed ventricular fibrillation in the rates of (b)(4).It was recommended that the patient continue amiodarone and mexilitine was considered for ventricular arrhythmia management.The arrhythmia was thought to be therapy related.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not conclusively be established through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), and no further related events have been reported at this time.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) is currently available.Section 1 ¿introduction¿ of this document lists cardiac arrhythmia and right heart failure as adverse events that may be associated with the use of the heartmate 3 lvas.Section 6, ¿patient care and management¿ (under ¿right heart failure), states that patients may develop right ventricular failure during or shortly after implant and outlines the associated treatment options.Section 6 (under ¿caution!¿) further explains that right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump.Additionally, section 6 lists arrhythmia as a potential late postimplant complication that may be associated with the use of heartmate 3 lvas.Although the patient¿s pneumonia was not considered to be device related, the ifu lists infection as an adverse event that may be associated with the use of the heartmate 3 lvas.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: 15079202
• MDR Text Key: 296346285
• Report Number: 2916596-2022-12235
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8431267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• 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; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian