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

Model Number UNK-PUMP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Hypovolemic Shock (1917); Septic Shock (2068); Respiratory Failure (2484); Multiple Organ Failure (3261); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/05/2021

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.This event occurred outside of the u.S.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) 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: impact of a surgical approach for implantation of durable left ventricular assist devices in patients on extracorporeal life support.Journal of cardiac surgery, april 2021;36(4):1344-1351.Doi: 10.1111/jocs.15401.Pmid: 33547707.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 compared clinical outcomes between full sternotomy versus less-invasive implantation techniques in left vad (lvad) patients who required pre-operative extracorporeal membrane oxygenation (ecmo).The data was based upon the ecls-vad european multi-center clinical registry.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 article reports patient deaths while on vad support, due to multiple organ dysfunction syndrome (mods), septic shock, strokes, heart failure, hemorrhagic shock and respiratory failure.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 sterility certificates could not be conducted since the serial numbers are unknown.Based on the available information, the devices may have caused or contributed to the reported events.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 course.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: 12866880
• MDR Text Key: 281191331
• Report Number: 3007042319-2021-08162
• 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: 01/11/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNK-PUMP
• Device Catalogue Number: UNK-PUMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/11/2022
• 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