• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE; VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 1103
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016); Appropriate Term/Code Not Available (3191)
Patient Problems Unspecified Infection (1930); Sepsis (2067); Tachycardia (2095); Ventricular Fibrillation (2130)
Event Date 10/27/2020
Event Type  Death  
Manufacturer Narrative
This information was received from the hvad destination therapy post approval study.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.
 
Event Description
It was reported that the patient had positive blood cultures for (b)(6) bacteremia leading to a ventricular tachycardia (vt)/ ventricular fibrillation "storm", which required antibiotics and surgical intervention.A ventricular assist device (vad) malfunction and thrombus were suspected.The patient subsequently died.
 
Manufacturer Narrative
A supplemental report is being submitted due to additional information received on the type of surgical intervention the patient was given.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.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
It was further reported that the surgical intervention that was performed was a ventricular tachycardia ablation.
 
Manufacturer Narrative
A supplemental report is being submitted for additional information and correction.Adverse event or product problem corrected from adverse event and product problem to adverse event.Device problem code(s) corrected from a27 to a24.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.
 
Event Description
It was further reported that during the ablation procedure the physician attempted to cross the aortic valve but the ventricular assist device (vad) flows dropped to zero and the patient subsequently expired.
 
Manufacturer Narrative
A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Review of the sterility certificate confirmed that the associated device met all requirements for release.Review of log files was not performed since log files were not available for analysis.As a result, the reported low flows and device malfunction could not be confirmed.There is insufficient information regarding the "device malfunction" event.Information received from the site indicated that the patient experienced positive blood cultures for methicillin-resistant staphylococcus aureus (mrsa) bacteremia, suspected thrombus, and a ventricular tachycardia (vt)/ ventricular fibrillation "storm".A ventricular tachycardia ablation was performed and the patient subsequently expired.Based on the available information, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event.Based on the risk documentation, possible causes of the 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, poor vad filling, inappropriate pump rotational speed.Per the instructions for use, infection, cardiac arrhythmias, thrombus, and death are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of infection.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.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.
 
Manufacturer Narrative
A supplemental report is being submitted for additional event information.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
It was further reported that the ventricular assist device (vad) malfunctioned twice requiring cpr.The patient also experienced elevated international normalized ratio (inr) and was noted to have subtherapeutic anticoagulation.Hd grid was advanced retrogradely across aortic valve.Left ventricle (lv) mapping was started and pacemaker turned off due to rhythm interference.Ventriculoatrial (va) dissociation also occurred and ablation catheter advanced into lv across aortic valve.No flow was noted on the vad and cpr was started.Cpr was stopped and vad was turned off.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
Type of Device
VENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
HEARTWARE, INC.
14400 nw 60th ave
miami lakes FL 33014
MDR Report Key10951234
MDR Text Key219762732
Report Number3007042319-2020-07569
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707003261
UDI-Public00888707003261
Combination Product (y/n)N
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/31/2021
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/05/2020
Supplement Dates Manufacturer Received12/23/2020
01/08/2021
01/29/2021
02/23/2021
Supplement Dates FDA Received12/29/2020
01/13/2021
02/04/2021
03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age64 YR
Patient Weight105
-
-