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 Hemorrhage/Bleeding (1888); Hypoglycemia (1912); Hypoxia (1918); Unspecified Infection (1930); Pleural Effusion (2010); Hypernatremia (2242); Obstruction/Occlusion (2422); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/08/2022

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 left pleural effusion.The pleural effusion was first seen on chest x-ray on (b)(6) 2022, but on (b)(6) 2022, bronchoscopy showed it to be compressing the left mainstem bronchus at the site of recurrent mucous plugs.The pleural effusion was removed and a chest tube placed on (b)(6) 2022 at which point 1l was immediately drained.The chest tube was removed on (b)(6) 2022.The patient had intermittent hypoxia requiring re-intubation on (b)(6) 2022 until the patient was extubated on (b)(6) 2022.There has been no recurrence following removal of left pleural effusion which was compressing bronchus.The patient was found to have elevated white blood cells and the infectious disease department was consulted.No diagnosis of infection was made, but the patient was given 3 days of empiric antibiotics.Leukocytosis resolved on (b)(6) 2022.

Manufacturer Narrative

Manufacturer's investigation conclusion a specific cause for the reported respiratory failure, cardiac arrhythmia, and patient conditions could not be conclusively determined.In addition, a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6) and the reported events could not be conclusively established.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 lvas, serial number (b)(6).No product is available for investigation.The current heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu), rev.C, lists respiratory failure and cardiac arrhythmia as adverse events that may be associated with the use of the hm3 lvas.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 26jul2022.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The endocrinology department was consulted on (b)(6) 2022 for stress hypoglycemia, and the patient was weaned off their insulin infusion and started on subcutaneous (sq) injections on (b)(6) 2022.

Event Description

It was reported that the patient experienced long episodes of atrial flutter resulting from left mainstem mucous plug.There was no mention of these arrhythmias following the removal of the mucous plug on (b)(6) 2022.After extubating on (b)(6) 2022, the patient gradually became more hypoxic requiring a bilevel positive airway pressure (bipap) machine, bronchoscopy following a chest-x ray showed opacity in the lower left lobe of the lung completely occluding the left mainstem bronchus.Of note, the electrophysiology (ep) consult diagnosed atrial flutter from pacemaker interrogation that differs from the interpretation of the electrocardiogram (ecg) taken on (b)(6) 2022.Ep consult reprogrammed the pacemaker to reduce potentially inappropriate treatments of this arrhythmia.On (b)(6) 2022 the patient developed abdominal pain.Kidney, ureter, and bladder x-ray revealed suspicions of ileus/small bowel obstruction; the patient was forbidden to take medication orally (npo).On (b)(6) 2022 a gastrointestinal (gi) consult confirmed suspicion of ileus/small bowel obstruction.The patient had a nasogastric tube placed for suction.The was no evidence of gastrointestinal bleed.The patient continued to be npo as of (b)(6) 2022.The incident was considered to have prolonged hospitalization.It was noted that the patient was randomized and received the first dose of the study drug on (b)(6) 2022 prior to being made npo.Additional information revealed that the patient had intermittent hypoxia from a recurrent mucous plug and associated left pleural effusion.The pleural effusion was removed and a chest tube placed on (b)(6) 2022 at which point 1l was immediately drained.The chest tube was removed on (b)(6) 2022.Hypoxia improved requiring re-intubation on (b)(6) 2022 until the patient was extubated on (b)(6) 2022.There has been no recurrence following removal of left pleural effusion which was compressing the bronchus at the site of the recurrent plugs.The patient was started on routine insulin intravenous (iv) infusion per protocol to prevent post-op hyperglycemia.However, the endocrinology department was consulted on (b)(6) 2022 for ,'stress hypoglycemia'.They were weaned off the insulin infusion and started on subcutaneous (sq) injections on (b)(6) 2022.They last dose of insulin of (b)(6) 2022.The patient was found to have elevated white blood cells after consulting with the infectious disease department.No diagnosis of infection was made, but the patient was given 3 days of empiric antibiotics.Leukocytosis resolved on (b)(6) 2022.It was found that patient had iron deficiency anemia for which they received an iron iv and 2 units of packed red blood cells.The patient's hemoglobin did not return to baseline until (b)(6) 2022.The patient's underlying right ventricular dysfunction was exacerbated due to concurrent respiratory failure, pleural effusion and recurrent bronchial plugging.The patient required increased inhaled nitric oxide, iv diuretics, and prolonged inotrope support.They were initially on dobutamine but were transitioned to milrinone prior to transfer to inpatient rehab.This right heart failure was expected in this patient and they returned to baseline at the fine of the transfer.Additionally, the patient had intermittent hypostatic orthostasis, or dizziness when standing, hypernatremia, and intermittent metabolic alkalosis.The patient received tolvaptan for several days to treat their hypernatremia until their serum sodium normalized.They were given acetazolamide (diamox) as needed for their intermittent metabolic alkalosis.The patient had exacerbation of renal dysfunction post-implant.The patient also had insomnia for which they revived gabapentin and melatonin.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the investigation conclusion is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion a specific cause for the reported events could not be conclusively determined.In addition, a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established.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 (hm) 3 left ventricular assist system (lvas), serial number (b)(6).The current heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu), rev.C, lists respiratory failure, cardiac arrhythmia, bleeding, and right heart failure as adverse events that may be associated with the use of the hm3 lvas.This document also provides information regarding anticoagulation, including recommended inr values, and the suggested anticoagulation modifications in the event that there is a risk of bleeding.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.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: 15470935
• MDR Text Key: 300455722
• Report Number: 2916596-2022-13638
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8567508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 12/01/2022; 12/01/2022; 03/06/2023
• Supplement Dates FDA Received: 12/05/2022; 03/03/2023; 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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): Life Threatening; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American