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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 Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Myocardial Infarction (1969); Right Ventricular Dysfunction (2054); Thrombus (2101); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Event Date 04/15/2020
Event Type  Injury  
Manufacturer Narrative
The patient transplant is covered under mfr # 2916596-2020-05850. 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 history of bacteremia of unclear origin. The patient's first positive blood cultures were drawn on (b)(6) 2020. It was additionally reported that the source of the infection was never fully identified. The patient had multiple indwelling lines at the time, so the infection could have been from a peripherally inserted central catheter (picc) or previous temporary right ventricular assist device (rvad). The patient's driveline never appeared infected, nor did it ever have any positive cultures. The patient also had a mobile echogenicity near the inflow cannula that was identified on echocardiogram (b)(6) 2020. It is unclear what the true source of the infection was. The patient initially complete 6 weeks of intravenous vancomycin and then transitioned to oral doxycycline for chronic suppression until their transplant. It was reported that the patient never had any clinical complications from the mobile echogenicity near the inflow cannula. When asked if the mobile echogenicity was considered to be thrombus, calcification, or bacterial vegetation, the vad coordinator responded by saying that it was considered thrombus because of the fact that it was small and disappeared in subsequent echocardiograms. The patient was placed on an rvad (abbott centrimag) at the time of implant as the patient was decannulated from extracorporeal membrane oxygenation (ecmo). At that time, the patient had a massive myocardial infarction (mi) which caused ventricular septal defect (vsd) and needed right ventricle (rv) support in additional to left ventricle (lv) support initially. The patient was decannulated from the rvad on (b)(6) 2020 and did well with his vad after discharge. The patient has since been transplanted. Of note, the patient underwent multiple transthoracic echocardiograms (tees) to track patient condition from (b)(6) 2020 to (b)(6) 2020. These tees noted moderate right ventricle (rv) enlargement and dysfunction, trace mitral regurgitation and mild tricuspid and aortic regurgitation. These tees are also how the clinicians visualized small thrombi in the inflow cannula and right coronary sinus, both of which dissipated.
 
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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 Key10992969
MDR Text Key220962275
Report Number2916596-2020-05910
Device Sequence Number1
Product Code DSQ
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/29/2022
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number7430524
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2020
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: 12/11/2020 Patient Sequence Number: 1
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