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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1103
Device Problem Increase in Suction (1604)
Patient Problems Unspecified Infection (1930); Pain (1994); Pleural Effusion (2010); Pulmonary Edema (2020); Cough (4457)
Event Date 07/07/2022
Event Type  Injury  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional information has been requested regarding the log files for this event, but it was not available at the time of this report. If log files investigation is performed, the event will be updated and a supplemental report will be sent. Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the ventricular assist device (vad) patient was admitted with elevated lactate dehydrogenase (ldh) from 339 to over 900, white blood cell count (wbc) of 15. 76 k/ul that increased to 18 k/ul, and complaint of cough, and right flank and back pain. The patient was worked up for suspected thrombus, but thrombus was not found. International normalized ratio (inr) was 4. 61 and plasma-free hemoglobin (hgb) was greater than 30. Abdomen/chest/pelvis computerized tomography (ct) showed a distended bladder. Pan cultures for sputum, urine, blood, and driveline site were taken. Infectious disease (id) was consulted and the patient was started on intravenous (iv) antibiotics. Procalcitonin and c-reactive protein (crp) levels were checked, and renal ultrasound was done. The patient had n-terminal pro b-type natriuretic peptide (nt-probnp) of 11892 on admission, with congestion and left pleural effusion seen on chest x-ray. The vad speed continued at 2400 rpm, no event was noted, but low perfusion index (pi). Review of logfiles showed one suction alarm approximately six weeks prior. The patient¿s mean arterial pressure (map) dropped in the 40s and they were given norepinephrine and taken to the intensive care unit (icu) to maintain maps. Computed tomography angiography (cta) of chest did not reveal vad thrombus. Bibasilar small pleural effusion with mild atelectasis in the lower lobes, and pulmonary venous congestion without overt pulmonary edema were observed. Inr was therapeutic at 2. 8 and warfarin was held until infection was ruled out. The patient had a thyroid stimulating hormone (tsh) level of 15. 3 with free thyroxine (t4) of 1. 06, and levothyroxine was increased. The vad remains in use. No further patient complications have been reported as a result of this event.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key15016579
MDR Text Key295900528
Report Number3007042319-2022-06557
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/31/2016
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: 07/14/2022 Patient Sequence Number: 1
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