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 Problem Pleural Effusion (2010)

Event Date 02/22/2020

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.Concomitant medical products: 419688 lead implanted (b)(6) 2009 7000 lead implanted (b)(6) 2008 1788tc lead implanted (b)(6) 2008 this information was received from the hvad destination therapy post approval study.Product event summary: ventricular assist device (vad) (b)(4) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information received from the site indicated that a chest x-ray that revealed that, two days post-implant, the patient had a small left pleural effusion.Based on the available information, including the occurrence of the event within two days of implant, the device may have caused or contributed to the reported event.Per the instructions for use, pleural effusion 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 is 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 had a chest x-ray that revealed a small left pleural effusion two days post ventricular assist device (vad) implant.The 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: 13560979
• MDR Text Key: 285844862
• Report Number: 3007042319-2022-02598
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2020
• Date Device Manufactured: 10/04/2018
• 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
• Treatment: DTBA1D1 ICD
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White