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

Model Number 1104

Device Problem Pumping Problem (3016)

Patient Problems Arrhythmia (1721); Tachycardia (2095)

Event Date 11/19/2020

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized due to ventricular tachycardia with recurrent palpitations and some dizzy spells.The ventricular assist device (vad) exhibited intermittent flow drop and a single low flow alarm.The patient was given oral medication.The ventricular assist device (vad) remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per d00700870.This information was received from the mechanical circulatory support product surveillance registry study.Product event summary: hw36514 was not returned for evaluation.The reported low flow event could not be confirmed as log files covering the reported event date were not available for analysis.Information received from the site indicated that, in addition to low flows, the patient experienced ventricular tachycardia (vt) with recurrent palpitations and some dizzy spells; the patient was given oral medication.Based on the limited information available, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to poor vad filling, thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or inappropriate pump rotational speed.Per the instructions for use, cardiac arrhythmia 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 vt.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, 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 are 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.

• 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: 15052969
• MDR Text Key: 296145827
• Report Number: 3007042319-2022-06639
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2021
• Date Device Manufactured: 07/02/2019
• 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; Hospitalization