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

Device Problems Electrical /Electronic Property Problem (1198); Obstruction of Flow (2423); Malposition of Device (2616); Battery Problem (2885); Deformation Due to Compressive Stress (2889); Pumping Problem (3016); Insufficient Information (3190)

Patient Problems Abscess (1690); Arrhythmia (1721); Hemolysis (1886); Hyperplasia (1906); Unspecified Infection (1930); Obstruction/Occlusion (2422); Syncope/Fainting (4411); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2020

Event Type  Injury  

Event Description

A journal article was reviewed which contained information regarding ventricular assist devices (vads).The article discussed the use of cardiac computed tomography (cct) to better determine the presence of left vad (lvad) complications and device malfunctions.Multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers.There were patients on vad support who were hospitalized and underwent cct and transthoracic echocardiographic imaging for suspected complications.Patients experienced pump/outflow graft (ofg) thromboses, causing pump alarms for altered pump flows/power, and obstruction caused by cannula malposition and ofg kinking.Treatment included lvad speed changes, surgical correction, percutaneous stenting, anticoagulation adjustments and pump exchanges.Patients also experienced neointimal cardiac hyperplastic growth, hemolysis, arrhythmias, syncope, congestive heart failure exacerbations, driveline infections, ofg infection/abscess and severe aortic regurgitation.The vads and ofgs remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific de vice information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers.The baseline gender/age of the patients represented in the article is male (b)(6).Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and, upon receipt, a supplemental report will be submitted accordingly.Referenced article: cardiac computed tomography improves the identification of cardiomechanical complications among patients with suspected left ventricular assist device malfunction.Journal of cardiovascular computed tomography, may-june 2021;15(3):260-267.Doi: 10.1016/j.Jcct.2020.08.008.Pmid: (b)(4) additional products: heartware ventricular assist system outflow graft: model #: unk / catalog #: unk / expiration date: unk / lot#: unk, udi #: (b)(4): no.Mfg date: unk, no: patient code(s): (b)(4): device code(s): (b)(4): fda results code(s): (b)(4): fda conclusion code(s): (b)(4) additional information has been requested regarding the cause of the events, device serial numbers and patient demographic data, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.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

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific de vice information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers.The baseline gender/age of the patients represented in the article is male (b)(6).Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and, upon receipt, a supplemental report will be submitted accordingly.Referenced article: cardiac computed tomography improves the identification of cardiomechanical complications among patients with suspected left ventricular assist device malfunction.Journal of cardiovascular computed tomography, may-june 2021;15(3):260-267.Doi: 10.1016/j.Jcct.2020.08.008.Pmid: 32891544 additional products: heartware ventricular assist system outflow graft: model #: unk / catalog #: unk / expiration date: unk / lot#: unk, udi #: (b)(4): no.Mfg date: unk, (b)(4).Additional information has been requested regarding the cause of the events, device serial numbers and patient demographic data, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.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

A journal article was reviewed which contained information regarding ventricular assist devices (vads).The article discussed the use of cardiac computed tomography (cct) to better determine the presence of left vad (lvad) complications and device malfunctions.Multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers.There were patients on vad support who were hospitalized and underwent cct and transthoracic echocardiographic imaging for suspected complications.Patients experienced pump/outflow graft (ofg) thromboses, causing pump alarms for altered pump flows/power, and obstruction caused by cannula malposition and ofg kinking.Treatment included lvad speed changes, surgical correction, percutaneous stenting, anticoagulation adjustments and pump exchanges.Patients also experienced neointimal cardiac hyperplastic growth, hemolysis, arrhythmias, syncope, congestive heart failure exacerbations, driveline infections, ofg infection/abscess and severe aortic regurgitation.The vads and ofgs remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: pumps and outflow grafts (ofgs) with unknown serial/lot numbers were not returned for evaluation.Review of the sterility certificates could not be conducted since the device serial/lot numbers are unknown.Review of the controller log files could not be conducted since log files were not available for analysis.As a result, the reported malposition, occlusion, high power, and low flow events could not be confirmed due to insufficient evidence.Visual evidence provided in the article revealed evidence of a thrombus and a kink within an ofg.Based on the available information, the devices may have caused or contributed to the reported events.Based on the information available, possible causes of the reported low flow events may be attributed but not limited to poor vad filling, thrombus in the ofgs and/or constriction of the ofgs.A possible root cause of the reported malposition events can be attributed, but not limited, to surgical technique during implantation.Based on the available information, the most likely root cause of the reported high-power events can be attributed to external factors such as thrombus formation/ingestion.Possible clinical factors that may have contributed to these events include patients¿ pre-existing histories and related comorbidities, the progression of their underlying diseases, issues related to the therapeutic use of anticoagulant and antiplatelet medications and their complex post-operative courses, including care of the driveline exit site.There are possible patient, pharmacological and procedural factors that may have contributed to these events.Additional products: d1: heartware ventricular assist system ¿ outflow graft d4: model #: unk / catalog #: unk / expiration date: unk / lot#: unk h6: method codes: 4112, 4114 h6: fda results codes: 180, 213 h6: fda conclusion codes: 19, 22 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.

• 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: 12859172
• MDR Text Key: 285323837
• Report Number: 3007042319-2021-08150
• Device Sequence Number: 1
• Product Code: DSQ
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male