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

Model Number 1103

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

Patient Problems Renal Failure (2041); Septic Shock (2068); Cardiogenic Shock (2262); Hypervolemia (2664); Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/22/2022

Event Type  Death  

Event Description

It was reported that the patient was admitted for cardiogenic shock, septic shock, hypervolemia, worsening right heart failure, and acute kidney injury. It was noted that the patient did not respond to aggressive diuretic therapy and was placed on continuous renal replacement therapy (crrt) along with subsequent intubation, increasing inotrope and vasopressor requirements due to further cardiogenic and septic shock. The patient began to have multisystem organ failure (msof) despite therapies by the cardiovascular (cv) surgery team. The patient condition worsened, and the organ system failure progressed to the point where family discussions began towards comfort measures. The patient was not a candidate for heart transplantation or other supportive interventions. A decision was made by the family to do not resuscitate (dnr) and began the process of withdrawal of vasopressor and inotropic support while providing maximum comfort measures. The patient subsequently expired from right ventricular failure and msof.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
• 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: 14171403
• Report Number: 3007042319-2022-04775
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: KG
• Patient Outcome(s): Death