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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 106524INT
Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Right Ventricular Dysfunction (2054); Low Cardiac Output (2501)
Event Date 03/29/2020
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 called a vad-coordinator on (b)(6) 2020 due to intermittent but regular low flow alarms since (b)(6) 2020. The patient also reported worsening from a general condition. The patient was readmitted on (b)(6) 2020 and an echo showed a small diameter of the left ventricle but a bad right ventricle function. Log files were downloaded and followed in a presumption of an obstruction somewhere in the inflow or outflow cannula. A ct angiography scan was scheduled for the next day. The scan showed a big obstruction/compression of the outflow graft beneath and directly in front of the outflow graft bend relief. A twist was not suspected at this time from the clinic. A re-exploration was completed on (b)(6) 2020. The surgeon prepared the old outflow graft over the entire length and during the preparation they noticed a hardened adhesion of very fatty tissue knots directly in front of the bend relief. The surgeon then opened the outflow graft bend relief with a pair of scissors. Beneath the bend relief was a small amount of jelly tissue was found but it did not explain the drop in flop. A twist was also excluded. The surgeon decided to change the whole outflow graft and installed an outflow graft clip. They checked the old graft for thrombus formation inside, but was also excluded. Flow began to increase to normal values. Hemodynamic was still restricted because of the bad right ventricle function. Cannulas were switched to an extracorporeal membrane oxygenation (ecmo) circulation device to relieve the right ventricle from higher volume load. Medical treatment via catecholamine therapy, volume therapy, volume substitution and transfer to the icu. An issue with the old outflow graft was excluded and the old one was disposed of.
 
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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 95488
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key9947673
MDR Text Key187304450
Report Number2916596-2020-01874
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011712
UDI-Public(01)00813024011712(10)6046643(17)200331
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2020
Device Model Number106524INT
Device Catalogue Number106524INT
Device Lot Number6046643
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2017
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: 04/10/2020 Patient Sequence Number: 1
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