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

Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889); Pumping Problem (3016)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Sepsis (2067); Stenosis (2263); Post Operative Wound Infection (2446); Respiratory Failure (2484); Pseudoaneurysm (2605); Diminished Pulse Pressure (2606); Multiple Organ Failure (3261); Hemorrhagic Stroke (4417); Ischemia Stroke (4418); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Restenosis (4576)

Event Date 10/08/2020

Event Type  Injury  

Event Description

A journal article was reviewed which contained information regarding ventricular assist devices (vads).The article discussed the incidence and treatment of outflow graft (ofg) narrowing/stenoses in vad patients.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.Ofg narrowing/stenosis was determined by chest computerized tomography (ct) scans and/or visual inspection during surgical intervention with evidence of biological debris causing external compression on the ofgs and reduced vad flows on waveform analysis.There were patients on vad support who experienced ofg narrowing/stenosis, including recurrent ofg stenoses, accompanied by hemodynamic deterioration in some patients.Interventions included percutaneous stenting, surgical decompression and urgent heart transplantation.During surgical interventions, complications included ofg kinking/torsion, ischemic/hemorrhagic strokes, right heart failure requiring temporary right vad (rvad) implantation, mediastinitis with septicemia, pseudoaneurysm, pump thrombosis, and multi-system organ dysfunction.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/59 years old.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: incidence, clinical relevance and therapeutic options for outflow graft stenosis in patients with left ventricular assist devices.American society for artificial internal organs journal, september 2021; pii: 6361014.Doi: 10.1093/ejcts/ezab382.Pmid: 34468714.Additional products: brand name: (b)(6).Model #: unk / catalog #: unk / expiration date: unk / lot#: unk.Udi #: (b)(4).Device available for evaluation: no.Mfg date: unk.Labeled for single use: yes.Patient ime code(s): (b)(4).Fda device 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

A supplemental report is being submitted for analysis/investigation completion.Product event summary: pumps with unknown serial numbers and outflow grafts with unknown lot numbers were not returned for evaluation.Review of the available log file screenshot in the article for one pump revealed a slight decrease starting on (b)(6) 2014 followed by a sudden decrease in power consumption and estimated flows on (b)(6) 2014.As a result, the reported low flow event was confirmed.Based on the available information, the device may have caused or contributed to the reported event.Based on risk documentation, multiple factors may have contributed to the low flow event including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.Visual evidence provided in the article revealed an obstruction of one outflow graft due to external compression from accumulated material that was trapped between the outflow graft and an additional surrounding graft placed by the surgeon at implant.As a result, the reported kink event was confirmed.The device may have caused or contributed to the reported event.Based on the available information, the most likely root cause of the reported event can be attributed to compression of the outflow graft from a foreign graft surrounding the outflow graft placed during implant.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 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.

• 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: 13519714
• MDR Text Key: 285618992
• Report Number: 3007042319-2022-02485
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2022
• 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: 04/27/2022
• 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
• Treatment: UNKNOWN VAD.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male