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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Hypoxia (1918); Renal Failure (2041); Right Ventricular Dysfunction (2054)
Event Date 07/28/2018
Event Type  Injury  
Manufacturer Narrative
The heartmate 3 lvas was implanted during the (b)(6) trial, ide# (b)(4). Fda approval for heartmate 3 lvas was received on 23 august 2017. The same device is used commercially and in the ongoing (b)(6). The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4). 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 was experiencing poor right ventricle (rv) function. The patient was failing to thrive following vad implant. The site claimed that the primary issue appeared to be rv dysfunction causing an acute kidney injury, also with significant hypoxemia. The patient is poorly responsive to diuretic. Will add ino via nc today. The site continued milrinone, hold diuresis. Allow mean arterial pressure to run 85. Continue foley catheter. Inotropes were started on (b)(6) 2018 and discontinued on (b)(6) 2018. Ino was started on (b)(6) 2018 and weaned off on (b)(6) 2018.
 
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Brand NameHEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
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 Key10656659
MDR Text Key210648221
Report Number2916596-2020-04869
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model Number106524
Device Catalogue Number106524
Device Lot Number6407126
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 Received10/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 10/09/2020 Patient Sequence Number: 1
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