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

Model Number 1103

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

Patient Problems Unspecified Infection (1930); Renal Failure (2041); Cardiogenic Shock (2262); Malaise (2359); Respiratory Failure (2484); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/14/2021

Event Type  Injury  

Event Description

It was reported that ventricular assist device (vad) patient experienced persistent low flow alarms, malaise, lightheadedness and worsening heart failure due to thrombosed vad.Patient had a left ventriculogram and aortogram which showed no forward flow in the outflow graft; therefore, no occlusion device was put in place and the vad was deactivated.Patient progressed to cardiogenic shock and required intubation and placement of an intra-aortic balloon pump (iabp).Patient developed end-stage renal disease (esrd) requiring hemodialysis (hd).Patient developed e coli bacteremia, and was removed from the highest status for transplantation.When the blood cultures eventually cleared, the patient status was reactivated to the highest status for transplant.About a month later, the patient underwent heart and kidney transplants.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Concomitant medical products: ddmb1d1 icd implanted (b)(6) 2017 additional products: heartware ventricular assist system- outflow graft; model #: 1125 / catalog #: 1125 / expiration date: unk/ serial#: (b)(4) udi #: (b)(4) device evaluated: no; mfg date: unk.Labeled for single use: yes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

###a supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) (b)(6) and the associated outflow graft (lot 1408975) were returned for evaluation.A review of the pump's manufacturing documentation confirmed that the associated device met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Review of log files was not performed since log files were not available for analysis.The reported low flow and occlusion events could not be confirmed due to insufficient evidence.Failure analysis of the returned outflow graft segment revealed that the device passed visual inspection.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Dimensional verification revealed that the front and rear housing disc curvatures were found to be deviating from release specifications.Internal pathology report revealed evidence of thrombus within the pump.Information received from the site indicated that the patient experienced malaise, lightheadedness, and worsening heart failure associated with a device thrombus.A left ventriculogram and aortogram revealed no forward flow in the outflow graft; therefore, no occlusion device was put in place and the vad was deactivated.The patient progressed to cardiogenic shock and required intubation and placement of an intra-aortic balloon pump.The patient also developed end-stage renal disease requiring hemodialysis, as well as e coli bacteremia.The patient later underwent heart and kidney transplants.Based on the available information, the device may have 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, and/or inappropriate pump rotational speed.Per the instructions for use, thrombus, worsening heart failure, respiratory dysfunction, infection, and renal dysfunction are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of similar adverse events.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.Additional products: d4: serial or lot#: 1408975 d9: yes, return date: (b)(6) 2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d12, d14 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: 13484645
• MDR Text Key: 289662061
• Report Number: 3007042319-2022-02416
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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: 694765 LEAD, 5076-45 LEAD
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 147 KG