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

Model Number 1103

Device Problems Failure to Pump (1502); Pumping Stopped (1503); Difficult to Remove (1528)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/08/2022

Event Type  Death  

Event Description

It was reported that the controller was four years old and the site wanted to perform an elective controller exchange to prevent a controller fault alarm triggering. An elective controller exchange was performed, and the pump did not restart when connected to the new controller. The connections were checked to verify that they were secure. The ventricular assist device (vad) speed went up to about 600 revolutions per minute (rpm) then went back down to zero rpm, and it was still alarming ¿vad stopped¿. Two minutes passed but the vad still wasn¿t starting. An attempt was made to connect the old controller, but that would not start the vad either. The new controller was attached again, and it was still alarming ¿vad stopped¿ so the patient was placed on extracorporeal membrane oxygenation (ecmo). It was stated that the controller stayed connected for about 20 minutes while the patient was placed on ecmo, but the vad did not restart. The patient was initially stable on ecmo but decompensated overnight, and an emergent vad exchange was performed. The dissection was difficult which made surgery more complicated. The patient was struggling and not doing well. Care was withdrawn and the patient subsequently died.

Manufacturer Narrative

Additional products: brand name: heartware ventricular assist system ¿ controller 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 30-apr-2020 / serial #: (b)(4)/ udi #: (b)(4). Device available for evaluation: yes, return date: 22-apr-2022. Mfg. Date: 10-apr-2019 labeled for single use: yes (b)(4). Additional products: brand name: heartware ventricular assist system ¿controller 2. 0, model #: 1420 / catalog #: 1420 / expiration date: 31-may-2022 / serial #:(b)(4) / udi #: (b)(4). Device available for evaluation: yes, return date: 22-apr-2022, mfg. Date: 27-may-2021. Labeled for single use: yes (b)(4). Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional information has been requested regarding the patient's weight and medical history, but it was not available at the time of this report. If additional information is received, the event will be updated and a supplemental report will be sent. 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: 14220149
• Report Number: 3007042319-2022-04863
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• 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
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0946-2021
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Outcome(s): Death