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

Model Number 106524US

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Septic Shock (2068); Cardiogenic Shock (2262); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

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 subject was transfused with 2 units of platelets intra-operatively during the lvad implantation.On (b)(6) 2021 the patient was reintubated due to significant secretions and hypoxia.A bronchoscopy was performed and cultures were positive for serratia marcescens.The patient was febrile and was treated with pressor support and cefepime.The patient was diagnosed with pneumonia.The patient experienced acute kidney injury (aki) secondary to the pneumonia.Pneumonia, respiratory failure, and potential worsening of heart failure events were assessed as related to the implantation procedure.On (b)(6) 2021 the patient's nasal culture was positive for methicillin-resistant staphylococcus aureus (mrsa) and they were treated with parenteral linezolid.The patient had frequent runs of non-sustained ventricular tachycardia (vt) post-operation and was given an amiodarone bolus and was started on an amiodarone iv drip.The patient experienced worsening right ventricular (rv) dysfunction post lvad implantation.The patient had cardiogenic shock and was in a hypercoagulable state.Pressor support was restarted along with inhaled veletri.On (b)(6) 2021 the patient had a hemoglobin level of 7.9 and was transfused with one unit of red blood cells (rbc) for further oxygen carrying capacity.On (b)(6) 2021 the patient received an additional unit of rbc.Cefepime was discontinued and meropenem was started for worsening septic shock.On (b)(6) 2021 the patient went into atrial fibrillation with rapid ventricular response and was treated with amiodarone boluses.The patient's automated implantable cardioverter defibrillator (aicd) cardioverted the patient.The patient's vt was preexisting to the lvad but atrial fibrillation did not exist prior to the device.On (b)(6) 2021 the patient had a tracheostomy placed and received an additional unit of rbc.The patient also had blood loss anemia.The patient was started on oral vancomycin on (b)(6) 2021 due to persistent fevers/leukocytosis and on (b)(6) 2021 the patient's cultures came back positive for clostridium difficile (c.Diff).On (b)(6) 2021 the patient had septic shock and suspected shock liver due to increased international normalized ratio (inr) or 1.7.On (b)(6) 2021, inr was 2.7, aspartate aminotransferase (ast) was 2286 units/l and alanine aminotransferase (alt) was 1391 units/l.The patient experienced worsening aki due to c.Diff infection.On (b)(6) 2021 the patient experienced worsening decompensation and received code dose epinephrine, sodium bicarbonate, and calcium.Iv flagyl and cefepime were added along with a one time gentamycin dose.A cooling blanket was given for a maximum temperature of 40 degrees celsius.Also on (b)(6) 2021, the patient received 3 units of rbcs for hemoglobin below 8.0 g/dl.There were no obvious signs of bleeding and the patient's hemoglobin after was 9.3 g/dl.On (b)(6) 2021 the patient's hemoglobin levels were 5.9 g/dl and they received 2 units of rbc.As of (b)(6)2021 the patient continued to require intensive care unit (icu) level of care for treatment of septic shock.On (b)(6) 2021, the patient had a right sided pleural effusion and a chest tube was placed.The patient's tracheal aspirate was positive to staphylococcus aureus and the patient was started on intravenous vancomycin and cefepime.The patient had a right sided hemothorax and the chest tube that was placed had 1.5l of bloody drainage.The tube clogged and a hemothorax redeveloped.The patient underwent another chest tube placement on (b)(6) 2021 with minimal bloody output.A head ct was obtained on (b)(6) 2021 due to a change in mental status.A new left pontine stroke was noted.No large vessel occlusion and a non-occlusive thrombus in the right internal jugular vein was noted.Neurology was consulted.

Manufacturer Narrative

Further information was received and this event was determined to be a duplicate to manufacturer report (mfr) number 2916596-2021-05826.The investigation conclusion and codes will be reported in mfr 2916596-2021-05826.

• 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: 12708579
• MDR Text Key: 278805908
• Report Number: 2916596-2021-05922
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8114821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 98 KG