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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Stroke/CVA (1770); Pneumonia (2011); Thromboembolism (2654)
Event Date 01/10/2022
Event Type  Injury  
Event Description
A journal article was reviewed that contained information regarding ventricular assist device (vad) driveline infection in pediatric patients. The article reports a patient who experienced a thromboembolic stroke in the middle cerebral artery and bilateral pneumonia. This patient and another patient both had driveline infections. The patients were admitted and treated with antibiotics; one patient had staphylococcus aureus and escherichia coli; the second patient had staphylococcus epidermidis. Surgical revision was planned. The skin around the exit site and the fibrous tissues around the drivelines were excised. The drivelines were mobilized from the subcutaneous tissues and washed with solution. The infected, partially necrotic wound bed was debrided until healthy uninfected tissues were seen. The drivelines were brushed to remove any adherent debris. The entire surgical field from the exit site of the driveline to the mediastinum was thoroughly irrigated with solution. The original skin exit sites were reused and no new exit point for the drivelines were fashioned. The subcutaneous space was closed with a suture. The skin edges were closed with interrupted non-absorbable monofilament sutures. Negative pressure therapy was applied to the surgical wounds for seven days, with the sponge dressing changed every three days. Aseptic wound dressing was then applied and changed daily for the next seven days. Parenteral antibiotic therapy was administered for a total of 14 days in the first case and 12 days in the second case. The status/disposition of the vads appear to be still in use. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. This event occurred outside the us. Patient information is limited due to confidentiality concerns. Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers. The baseline gender/age characteristics is unknown. The model listed in the report is a representative of the model family, as there is no specific model listed. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: eradication of ventricular assist device driveline infection in pediatric patients with taurolidine. Journal of cardiovascular development and disease. 2022, 9, 18. Doi: 10. 3390/jcdd9010018. Investigation of this event is pending, and a supplemental report will be sent upon its completion. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
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 Key14632249
MDR Text Key293548155
Report Number3007042319-2022-05354
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/08/2022 Patient Sequence Number: 1
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