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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pleural Effusion (2010); Pulmonary Edema (2020); Chills (2191)
Event Date 12/27/2019
Event Type  Injury  
Manufacturer Narrative
This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation. Product event summary: ventricular assist device (vad) (b)(4) was not returned for evaluation. This complaint is associated with a clinical adverse event. Information received from the site indicated that the patient had intermittent cough for two weeks and presented to the emergency department (ed) with chills. The chest x-ray was unremarkable and there was no evidence of infection; however, did show mild pulmonary edema and bilateral pleural effusions. The patient was administered iv diuretics. Based on the available information, the device may have caused or contributed to the reported event. Per instructions for use, respiratory dysfunction and pleural effusion are known potential complications associated with the implantation of a vad. There was no evidence that the patient had a history of similar adverse events. Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course. There is possible patient, pharmacological and procedural factors that may have contributed to this event. Investigation of this event is completed and the file will be closed. If new information is received, the file will be re-opened and a supplemental will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient had intermittent cough for two weeks and presented to the emergency department (ed) with chills. A chest x-ray was concerning for possible pneumonia and the patient was started on intravenous (iv) antibiotics. The chest x-ray was unremarkable and there was no evidence of infection. It was further reported that the chest x-ray, however, did show mild pulmonary edema and bilateral pleural effusions. The patient was administered iv diuretics. The ventricular assist device (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 Key13552107
MDR Text Key285774236
Report Number3007042319-2022-02566
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707003261
UDI-Public00888707003261
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 Study,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/17/2018
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: 02/17/2022 Patient Sequence Number: 1
Treatment
6935M62 LEAD, 407645 LEAD, 419688 LEAD,DTBA1D4 ICD
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