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

Model Number 1103

Device Problems Pumping Problem (3016); Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Hemorrhage/Bleeding (1888); Dizziness (2194); Diaphoresis (2452); Respiratory Arrest (4461)

Event Date 12/24/2021

Event Type  Death  

Event Description

It was reported that the patient was "having a normal night" when the patient stated they felt dizzy and had chest pain.The patient's spouse noted that they took the patient's temperature and watched the patient "drink water all day".When the patient "went to get up" the patient "had black out sessions".The patient's spouse helped the patient to the toilet, and that is when the patient requested to call 911.The patient's spouse noted that the ventricular assist device (vad) "low flow alarms were going off" and emergency medical services (ems) silenced the alarms.The patient was pale, diaphoretic, ashen, and agitated per the paramedic when ems arrived at the home.The patient reportedly passed away in the ambulance.According to the emergency department (ed) notes, the patient respiratory arrested in the ambulance and was intubated.The ed nurse stated there was speculation of a gastrointestinal bleed (gib) which was later confirmed.The actual cause of death remained unknown.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental is being submitted for investigation complete and additional information.Additional information: - b5 desc evt problem: additional information regarding device analysis finding for a returned controller - h10 addt manufacturer for mdr: additional product details updated additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420/ catalog #: 1420/ expiration date: 31-oct-2019 / serial #: (b)(6), udi #: (b)(4).D9: yes, return date: 16-feb-2022 h3: yes dev rtn to mfr? yes h4: mfg date: 31-oct-2018 h5: no h6: patient ime code(s): e233001, e0112, e0741, e2310, e0506 h6: imf code(s): f23, f22, f02 h6: img code(s): g04034, g0201402 h6: fda device code(s): a27 h6: fda method code(s): b15, b01 h6: fda results code(s): c07, c15 h6: fda conclusion code(s): d11 product event summary: ventricular assist device (vad) hw31293 was not returned for evaluation.One controller (b)(6), was returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the devices in relation to the reported event.Failure analysis of (b)(6) revealed that the device passed functional testing.Visual inspection of (b)(6) revealed contamination within both power ports, the serial port, and the pump connector.Additionally, visual inspection revealed scratches on the controller's liquid crystal display (lcd) on the front panel window; however, the observed scratches did not interfere with the functionality of the display.The observed contamination and scratches on the display are additional findings not related to the reported event, likely due to the handling of the device.Review of the controller log files associated with con403416 revealed a sudden decrease in power consumption and estimated flows leading to parameters below the normal operating range on 24-dec-2021 and six (6) low flow alarms logged on 24-dec-2021.As a result, the reported low flow event was confirmed.Information provided by the site indicated that the pa tient felt dizzy and had chest pain and later experienced ¿black out sessions".The patient was pale, diaphoretic, ashen, and agitated per the paramedic when emergency medical services arrived at the home.The patient respiratory arrested in the ambulance and was intubated.There was speculation of a gastrointestinal (gi) bleed which was later confirmed.The cause of death was unknown.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or poor vad filling.Per the instructions for use, gi bleeding, neurological dysfunction, respiratory dysfunction, cardiopulmonary arrest, and death are known potential complication associated with the implantation of a vad.There was no evidence that 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 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.### medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The controller was returned to the manufacturer because it was not charging.Manufacturer¿s analysis revealed an environment problem identified and mechanical problem identified.No 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: 13193161
• MDR Text Key: 283413946
• Report Number: 3007042319-2022-00074
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Date Device Manufactured: 12/06/2017
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 104 KG