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

Model Number 1104

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pneumonia (2011); Urinary Tract Infection (2120); Cough (4457)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per d00700870.This information was received from the psr mcs therapy base.Product event summary: ventricular assist device (vad) hw29352 was not returned for evaluation.This complaint is associated with a clinical adverse event.Review of the sterility certificate confirmed that the associated device met all requirements for release.Information provided by the site indicated that the patient experienced pneumonia with increased c-reactive protein and sputum.A bacterium was detected, and the patient was treated with intravenous (iv) antibiotics.The patient later experienced a urinary tract infection and bacterial infection was detected; the patient was again treated with iv antibiotics.Two days later, the patient experienced cough and sputum increase, as well as abnormal rhythm, and the patient¿s antibiotic medication was adjusted.Based on the limited information available, the device may have caused or contributed to the reported event.Per the instructions for use, infection is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of infection.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, 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 experienced pneumonia and increased c-reactive protein (crp) and sputum.It was further reported that a bacterium was detected, and the patient was subsequently treated with antibiotics via intravenous (iv).Approximately thirty-six days later, the patient experienced urinary tract infection (uti) and bacterial infection was detected, the patient was again treated with antibiotics via iv.Two days later, the patient experienced cough and sputum increase as well as abnormal rhythm.The patient¿s antibiotic medication was adjusted and after approximately nine days later, it was stated that the patient¿s condition recovered though they continued on some antibiotic medication.The ventricular assist device (vad) remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: VENTRICULAR (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 Key: 15032370
• MDR Text Key: 296005966
• Report Number: 3007042319-2022-06586
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2020
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention