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 High Blood Pressure/ Hypertension (1908); Nausea (1970); Blurred Vision (2137); Anxiety (2328); Fungal Infection (2419); Fluid Discharge (2686); Heart Failure/Congestive Heart Failure (4446); Renal Impairment (4499)

Event Date 03/28/2022

Event Type  Injury  

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 had a plum-size swelling and tenderness at the base of the sternal scar on (b)(6) 2022.The patient scheduled a procedure in the ventricular assist device (vad) clinic on (b)(6) 2022.The patient was admitted for possible incision and drainage on (b)(6) 2022.Wound cultures were obtained on (b)(6) 2022 in the operating room (or).The patient was started on vancomycin and cefepime.Additional information revealed that the patient had worsening shortness of breath.On (b)(6) 2022, 100 ml of drainage was removed, the wound was packed and antibiotics given.The wound culture revealed candida albicans.They were given 80 mg of lasix iv in the early morning of (b)(6)2022.Upon examination, the patient's neck veins were found to be distended with continued shortness of breath.Another 120mg iv of lasix was given.On (b)(6) 2022, the patient had nausea, and lightheadedness, and reported seeing "clouds".They received a 5mg iv of hydralazine, however, the patient remained hypertensive.A second 10mg dose was given after which the patient's condition improved and their blurry vision resolved.On (b)(6) a computerized tomography scan revealed no more fluid had collected in the wound.At 0515, the patient had shortness of breath and was given hydroxyzine.The patient had a return to flow (rtf) of 70-108 and on (b)(6) 2022 they had an rtf of between 90-101.On (b)(6) 2022, the patient started taking fluconazole orally and social services were consulted for home wound care.On (b)(6) 2022 the patient's white blood cell (wbc) level was 9.1.On (b)(6) 2022, the patient's rtf was 90-112 and they began taking 10 mg hydralazine three times a day.On (b)(6) 2022 a wound vac was placed.As of (b)(6) 2022 the patient was stable.

Event Description

The patient was discharged home on (b)(6) 2022 on 75mg twice daily spironolactone, a 25 daily course of metoprolol, and a 10mg course of hydralazine three times a day.Additional information revealed that the patient had chest pain located where the lvad was located.The patient reported not having the fluconazole that was prescribed on discharge from the hospital.On 1(b)(6) 2022 the patient was presented to the emergency department with volume overload.Creatinine upon admission was 1.77.The patient received 200 milligrams of intravenous lasix (furosemide).The patient reported sharp pain at the incision site from the incision and drainage.The wound vac was not changed since the patient was discharged on (b)(6) 2022.A chest x-ray and computed tomography scan of the chest/abdomen/pelvis were obtained and were unremarkable.The patient was overloaded with jugular vein distention, orthopnea, and crackles in the lungs.On (b)(6) 2022 the patient's creatinine was 2.93.Spironolactone was held for one day.The patient reported dysuria.There was no evidence of obstruction.On (b)(6) 2022 the patient was put back on a lasix drip.On (b)(6) 2022 the patient was started on dobutamine and continued with lasix.

Manufacturer Narrative

Section a4: patient privacy laws prohibit the release of private patient information and patient date of birth should have been removed from the previous report.Main investigation conclusion: a direct correlation between the device and the reported infection, hypertension, renal dysfunction, and patient conditions could not be conclusively established through this investigation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.The heartmate 3 left ventricular assist system instructions for use, rev.C, lists local infection, driveline or pump pocket infection, hypertension, and renal dysfunction as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.This ifu and the heartmate 3 lvas patient handbook both outline care instructions for preventing infection.The ifu states that post-implantation hypertension may be treated at the discretion of the attending physician, and any therapy that consistently maintains mean arterial blood pressure less than 90 mm hg should be considered adequate.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on (b)(6) 2021.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: 14137242
• MDR Text Key: 290559108
• Report Number: 2916596-2022-10212
• 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
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8048008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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): Life Threatening; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American