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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adult Respiratory Distress Syndrome (1696); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pneumonia (2011); Septic Shock (2068); Thrombosis/Thrombus (4440)
Event Date 09/23/2021
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 patient was admitted on (b)(6) 2021 for major bleeding and was given a blood transfusion. The patient's hemoglobin dropped to 6. 7 g/dl and was up to 8. 3 g/dl. On (b)(6) 2021 lab test, hypernatremia was found. The renal team was consulted, and continued with 40mg twice a day lasix and adjusted dextrose 5% in water. On (b)(6) 2021 the patient developed a major infection and had fever (38. 4c and diarrhea). The patient failed to thrive and was returned to the intensive care unit (icu). Lab cultures showed no growth and was started on vancomycin and cefepime. On (b)(6) 2021 the patient developed anemia and their hemoglobin dropped to 6. 6 g/dl and another transfusion of 1 unit packed red blood cells was given. The patient was in acute respiratory distress syndrome (ards) with showing signs of sepsis and septic shock, possible secondary to hospital acquired pneumonia in the setting of hypernatremia. The lvad was at 6000 rpm. Milrinone was continued at 0. 125, stress dose steroids, and continued meropenem. They were on ventilatory support, status/post bronchoscopy twice with diffuse bleeding and friable tissue. The patient also developed a major infection but cultures negative of growth to date ¿ potentially bacterial pneumonia but pending any positive cultures. On (b)(6) 2021 the patient underwent a bronchoscopy with minimal secretions in their airway. On (b)(6) 2021 the patient was intubated for respiratory failure. On (b)(6) 2021 the patient was reintubated for ards and was treated with percutaneous tracheostomy and bronchoalveolar lavage. There was also some blood oozing from the tracheostomy packing. Hemoglobin and hematocrit stable. The patient was afebrile.
 
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Brand NameHEARTMATE 3 LVAS IMPLANT KIT
Type of DeviceVENTRICULAR (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 Key12674387
MDR Text Key277710725
Report Number2916596-2021-05805
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013297
UDI-Public00813024013297
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number8088430
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/21/2021 Patient Sequence Number: 1
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