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

Model Number 1103

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

Patient Problems Dyspnea (1816); Pleural Effusion (2010); Respiratory Failure (2484); Ascites (2596)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.Product event summary: (b)(4) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information received from the site indicated that the patient experienced respiratory dysfunction; the patient was hospitalized for shortness of breath with desaturation and had a tracheotomy.A computerized tomography (ct) scan showed complete atelectasis of the left lung, bilateral pleural effusions, mucous plug, and ascites, and the patient required dialysis for fluid removal.Based on the limited information available, the device may have caused or contributed to the reported event.Per the instructions for use, respiratory dysfunction and pleural effusion are known potential complications associated with the implantation of a vad.There was no evidence the patient had a history of similar adverse events.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.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 respiratory dysfunction.The patient was hospitalized for shortness of breath (sob) with desaturation and had a tracheotomy.Computerized tomography (ct) scan showed complete atelectasis of the left lung, bilateral pleural effusions, mucous plug, and ascites.Ear, nose, and throat (ent) and pulmonary were consulted.The patient required dialysis for fluid removal.The patient was discharged to long term acute care (ltac) almost a month later.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: 13581177
• MDR Text Key: 288986426
• Report Number: 3007042319-2022-02637
• 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
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2020
• Date Device Manufactured: 11/29/2018
• 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; Life Threatening; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 127 KG