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

Model Number MCS1705PU

Device Problem Pumping Problem (3016)

Patient Problems Stroke/CVA (1770); Fatigue (1849); Muscle Weakness (1967); Thrombosis/Thrombus (4440)

Event Date 10/11/2023

Event Type  Death  

Event Description

It was reported that the patient was admitted with right posterior cerebral artery (pca) cerebrovascular accident (cva) and discharged to inpatient rehab facility. over the course of the week, there was an uptrend in power consumption on ventricular assist device (vad) and increase in lactate dehydrogenase (ldh).The patient was deemed not a candidate for vad exchange after discussion with the medical team.The patient was started on 24 hour tissue plasminogen activator (tpa) which normalized vad power and ldh.About a month after, there was another rise in vad power and suspect of pump thrombus.Tpa therapy was declined by the patient and family.The patient was released home on hospice care.Couple days after the patient was growing more tired and weak and it was decided to discontinue pump support.The patient passed away and shortly after the vad was turned off.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18992504
• MDR Text Key: 338811373
• Report Number: 3007042319-2024-01374
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707005364
• UDI-Public: 00888707005364
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: MCS1705PU
• Device Catalogue Number: MCS1705PU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Date Device Manufactured: 08/19/2020
• 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): Death
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 109 KG