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

Model Number 1103

Device Problem Pumping Problem (3016)

Patient Problems Anemia (1706); Atrial Fibrillation (1729); Stroke/CVA (1770); Hemolysis (1886); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Hematuria (2558); Paresthesia (4421); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450); Unspecified Heart Problem (4454)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

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

It was reported that the patient presented with hematuria noted from an indwelling foley catheter, ventricular assist device (vad) high watt alarms, and pump thrombosis.The patient was placed on dobutamine, heparin, and sodium bicarbonate drip.The patient required increased in oxygen per arterial blood gas (abg) test results.Mean arterial pressure (map) was above goal, international normalized ratio (inr) was 1.2, hemoglobin (hgb) was 9.4, lactate dehydrogenase (ldh) was 3,758, and the patient was in active vad hemolysis.Echocardiogram showed the left ventricle cavity size was dilated, systolic function was severely reduced, severe global hypokinesis, and the ejection fraction (ef) was 25%.Aortic valve had moderate regurgitation and the aorta was mildly dilated.The estimated peak pressure is 19 mm/hg.Transthoracic echocardiogram (tte) aortic insufficiency and mild right ventricle (rv) dysfunction.The patient received torsemide and tissue plasminogen activator (tpa) with resolution of elevated vad powers and hematuria as well as improvement in vad flows.The patient was weaned off all intravenous (iv) medications.Three days later, head computerized tomography (ct) was done for tpa protocol and showed a right occipital-parietal infarct.Neuro exam revealed decreased sensation and tingling along left arm which improved.The patient was started on high intensity heparin drip (gtt) and continued on coumadin.The patient went into atrial fibrillation (af) with rapid ventricular response (rvr) and became hypotensive.The patient was given amiodarone and was converted back into sinus rhythm.It was noted that the patient¿s maps were below goal, ldh was 1,980, inr was 1.1, and hgb was 7.8.The patient was transfused packed red blood cells (prbc) and hgb level became stable.Repeat head ct was negative and it was noted that the driveline exit site was tender and felt sore.Heparin drip was discontinued, and the patient was discharged home.The vad remains in use.No further patient complications have been reported as a result of this event.

Event Description

It was further reported that the patient had acute kidney injury (aki) on stage three (3) chronic kidney disease thought to be secondary to chronic cardiorenal syndrome.Blood urea nitrogen (bun) was 21 and creatinine (cr) was 2.11.

Manufacturer Narrative

A supplemental report is being submitted for correction.Correction b5: describe event problem was corrected to include additional patient signs/symptoms and diagnostic results.Correction h6: patient ime code was updated.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.

Manufacturer Narrative

A supplemental report is being submitted for investigation summary.Product event summary: the ventricular assist device (vad) (b)(6) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information received from the site indicated that the patient was admitted for frequent runs of non-sustained ventricular tachycardia (nsvt).The patient was asymptomatic and electrophysiology (ep) was consulted.The settings on the implantable cardioverter defibrillator (icd) were adjusted to prevent therapy.The patient denied palpitations and expressed wishes to stop icd therapies.Of note, information received indicated that the event was not related to the vad.Based on the available information, including the statement by the physician that the event is unrelated to the device, the device most likely did not cause or contribute to the reported event.Per the instructions for use, cardiac arrhythmia is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of cardiac arrhythmia.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/DRIVELINE
• 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: 14876064
• MDR Text Key: 295141990
• Report Number: 3007042319-2022-06354
• 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,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Date Device Manufactured: 05/31/2016
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female