MAUDE Adverse Event Report: HEARTWARE INC.

Device Problem Positioning Problem (3009)

Patient Problem Tachycardia (2095)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Product event summary: a pump with unknown serial number was not returned for evaluation.Review of the controller log files could not be conducted since log files were not available.Based on the limited information available, the device may have caused or contributed to the reported event.Based on the risk documentation and available information, the most likely root cause of the reported event can be attributed to inappropriate positioning of the pump.Per the instructions for use, vt is a known potential complication associated with the implantation of a vad.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 are possible patient, pharmacological and procedural factors that may have contributed to this event.This event was reported in the q4 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the 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.

Event Description

It was reported that post ventricular assist device (vad) implant the vad spontaneously moved out of position and was unable to re-position.This required removal and reinsertion of new vad.The malpositioning was diagnosed via chest x-ray.The patient experience ventricular tachycardia (vt) that was caused by malposition and requiring two shocks and "pulling".The vad was exchanged.No further patient complications have been reported as a result of this event.This event was reported in the q4 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.

• Manufacturer (Section D): HEARTWARE INC.; 14400 nw 60th ave; miami lakes FL 33014 0000
• 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: 13829184
• MDR Text Key: 287524851
• Report Number: 3007042319-2022-04024
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Date Manufacturer Received: 02/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White