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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 Dyspnea (1816); Hypoxia (1918); Pleural Effusion (2010); Pulmonary Edema (2020); Tachycardia (2095); Cough (4457)
Event Date 01/05/2022
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
The patient presented to the emergency center on (b)(6) 2022 with dyspnea where he was found to be hypoxic (89-91%) on room air which improved with 2l of nasal o2/ chest x-ray that showed mild pulmonary edema with small bilateral pleural effusions. Right > left edema with intermittent cough. The patient was admitted on (b)(6) 2022 and was given 2 mg intravenous bumex and had significant urine output. The patient was admitted to the floor for further management. On (b)(6) 2022 the patient stated his symptoms had significantly improved but he remained on 2l. The patient was also noted to have intermittent increase in pulsatility index (pi) events occurring in clusters (morning, afternoon, and late night). No changes were made to the device. Additional information stated that the subject had intermittent lab values where potassium was 3. 3 during two consecutive days. The patient was reported to have non-sustained ventricular tachycardia with shortness of breath and cough. Basal metabolic labs showed mild hypokalemia on (b)(6) 2022. This was treated with oral potassium tablets that were likely caused by diuretic therapy.
 
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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 Key13346989
MDR Text Key287543464
Report Number2916596-2022-00252
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number7975741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2021
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: 01/25/2022 Patient Sequence Number: 1
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