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

Device Problems Obstruction of Flow (2423); Pumping Problem (3016)

Patient Problems Intracranial Hemorrhage (1891); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/15/2022

Event Type  Death  

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 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 pediatric patients represented in the article is male/53 years old.The dates of death are not available at the time of this report as there is no indication of specific serial number/patient information.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: fox h.; et al.Evolution of thrombolytic therapy in patients with heartware ventricular assist device thrombosis: a single-institutional experience.Interact cardiovasc thorac surg.2022 jun 15;35(1).Pii: 6540697.Doi: 10.1093/icvts/ivac054.Pmid: 35234899 publisher: interact cardiovasc thorac surg 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 a single german medical center¿s experience with changing thrombolysis protocols and reported clinical outcomes.Multiple patients were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers.The article reports patient deaths while on vad support, after experiencing pump thromboses and being hospitalized with heart failure symptoms.The pumps exhibited low flow with increased power consumption and pulsatility.The patients underwent laboratory and imaging diagnostic workups, and most underwent intravenous (iv) thrombolytic therapy.Three patients developed severe intracerebral bleeding (icb) after thrombolysis, resulting in death.Seven patients with contraindications to thrombolytic therapy underwent surgical pump exchanges, but later died within 12 months post-surgery, however their causes of death were not reported.The status of the vads is unknown.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: pumps with unknown serial numbers were not returned for evaluation.Review of the available log file screenshots from the article revealed several increases and decreases in power consumption and estimated flow parameters outside normal operating range during the analyzed periods.Additionally, visual evidence provided in the article revealed evidence of thrombus within the device.As a result, the reported high-power, low-flow, and device thrombus events were confirmed.The reported device occlusion events could not be confirmed due to insufficient evidence.Based on the available information, the device may have caused or contributed to the reported events.Based on the available information and historical review of similar events, the most likely root cause of the high-power events can be attributed to external factors such as thrombus formation/ingestion.Based on the risk documentation, possible causes of the low-flow events 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.Possible clinical factors that may have contributed to these events include the 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 the patients¿ complex post-operative courses.There are possible patient, pharmacological and procedural factors that may have contributed to these events.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: 15126145
• MDR Text Key: 296838571
• Report Number: 3007042319-2022-06746
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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
• Date Manufacturer Received: 09/30/2022
• 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): Death
• Patient Age: 53 YR
• Patient Sex: Male