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

Model Number 1103

Device Problem Increase in Suction (1604)

Patient Problems Unspecified Infection (1930); Pain (1994); Pleural Effusion (2010); Pulmonary Edema (2020); Cough (4457)

Event Date 07/07/2022

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional information has been requested regarding the log files for this event, but it was not available at the time of this report.If log files investigation is performed, the event will be updated and a supplemental report will be sent.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.

Event Description

It was reported that the ventricular assist device (vad) patient was admitted with elevated lactate dehydrogenase (ldh) from 339 to over 900, white blood cell count (wbc) of 15.76 k/ul that increased to 18 k/ul, and complaint of cough, and right flank and back pain.The patient was worked up for suspected thrombus, but thrombus was not found.International normalized ratio (inr) was 4.61 and plasma-free hemoglobin (hgb) was greater than 30.Abdomen/chest/pelvis computerized tomography (ct) showed a distended bladder.Pan cultures for sputum, urine, blood, and driveline site were taken.Infectious disease (id) was consulted and the patient was started on intravenous (iv) antibiotics.Procalcitonin and c-reactive protein (crp) levels were checked, and renal ultrasound was done.The patient had n-terminal pro b-type natriuretic peptide (nt-probnp) of 11892 on admission, with congestion and left pleural effusion seen on chest x-ray.The vad speed continued at 2400 rpm, no event was noted, but low perfusion index (pi).Review of logfiles showed one suction alarm approximately six weeks prior.The patient¿s mean arterial pressure (map) dropped in the 40s and they were given norepinephrine and taken to the intensive care unit (icu) to maintain maps.Computed tomography angiography (cta) of chest did not reveal vad thrombus.Bibasilar small pleural effusion with mild atelectasis in the lower lobes, and pulmonary venous congestion without overt pulmonary edema were observed.Inr was therapeutic at 2.8 and warfarin was held until infection was ruled out.The patient had a thyroid stimulating hormone (tsh) level of 15.3 with free thyroxine (t4) of 1.06, and levothyroxine was increased.The vad remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

### a supplemental report is being submitted for device evaluation.Product event summary: hw28260 was not returned for evaluation.The reported suction alarm event was confirmed via review of the available autologs report, which revealed one (1) suction alarm logged on (b)(6) 2022, as well as a slight decrease in power consumption and estimated flow starting on (b)(6) 2022.Information provided by the site indicated that the patient was admitted with elevated lactate dehydrogenase (ldh) and white blood cell count (wbc) and complaint of cough and right flank and back pain.An abdomen/chest/pelvis computerized tomography showed a distended bladder.Additionally, pan cultures for sputum, urine, blood, and the driveline site were taken, and the patient was started on intravenous antibiotics.The patient had n-terminal pro b-type natriuretic peptide (nt-probnp) of 11892 on admission, with congestion and left pleural effusion seen on a chest x-ray.The patient¿s mean arterial pressure (map) dropped in the 40s and they were given norepinephrine.Bibasilar small pleural effusion with mild atelectasis in the lower lobes and pulmonary venous congestion without overt pulmonary edema were also observed.Of note, the patient was worked up for suspected thrombus, but thrombus was not found.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 suction alarm and the observed 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, pleural effusion and infection 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.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: 15016579
• MDR Text Key: 295900528
• Report Number: 3007042319-2022-06557
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: 00888707000017
• 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: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2016
• 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): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 76 KG