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

Model Number 1103

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

Patient Problems Bacterial Infection (1735); Headache (1880); Intracranial Hemorrhage (1891); Renal Failure (2041); Vomiting (2144); Dysphasia (2195); Multiple Organ Failure (3261)

Event Date 02/12/2022

Event Type  Death  

Event Description

It was reported that the patient presented to the emergency room with horrible headache, vomiting, and ¿talking nonsense¿, and the patient was admitted for a work up.A computed tomography (ct) scan of the head showed spontaneous head bleed with subarachnoid hemorrhage (sah).Serial ct scans of the head were captured and showed improvements.A brain angiogram was done showing no aneurysms.A neurovascular brain procedure showed that the patient had brain softening encephalomalacia in the anterior right temporal lobe, possibly related to trauma.Hematology studies were taken and international normalized ratio (inr) on admission was 2.5.The patient was compliant with anticoagulation and was given vitamin k and a prothrombin complex concentrate.16 days after admission, the sah was near resolution.The ventricular assist device (vad) remains in use.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: the ventricular assist device (vad) (b)(4) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information provided by the site indicated that the patient presented to the emergency room with horrible headache, vomiting, and ¿talking nonsense¿, and the patient was admitted for a work up.A computed tomography (ct) scan of the head showed spontaneous head bleed with subarachnoid hemorrhage (sah).Serial ct scans of the head were captured and showed improvements.A brain angiogram was done showing no aneurysms.A neurovascular brain procedure showed that the patient had brain softening encephalomalacia in the anterior right temporal lobe, possibly related to trauma.Hematology studies were taken and international normalized ratio (inr) on admission was 2.5.The patient was compliant with anticoagulation and was given vitamin k and a prothrombin complex concentrate.16 days after admission, the sah was near resolution.Additional information received from the site indicated that the patient continued declining and had expired after a long hospitalization almost two (2) months later.The patient was on continuous venovenous hemodialysis (cvvhd), had vegetation on an implantable cardioverter defibrillator (icd) lead, and was bacteremic needing pressors.The patient experienced multiple systems organ failure (msof) and care was withdrawn when the patient was maxed out on pressors.The cause of death was due to multi-system organ failure (msof) and withdrawal of care.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, neurological dysfunction, renal dysfunction, sepsis, multi-organ failure, and death are 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 neurological dysfunction and infection.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Additional information was received regarding patient final outcome.Outcome attributed to adverse event was updated from hospitalization and intervention required to death.Date of death was added.Description event problem was updated to include the additional patient signs/symptoms, clinical actions, and patient's death.Laboratory data was updated to include diagnostic test results.(b)(4).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 further reported that the patient continued declining and had expired after a long hospitalization almost two (2) months later.The patient was on continuous venovenous hemodialysis (cvvhd), had vegetation on an implantable cardioverter defibrillator (icd) lead, and was bacteremic needing pressors.Patient was in multiple systems organ failure (msof) and care was withdrawn when the patient was maxed out on pressors.The cause of death was due to msof/withdrawal of care.

• 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: 13938593
• MDR Text Key: 288109657
• Report Number: 3007042319-2022-04472
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/27/2022
• 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
• Treatment: 638RL30 HEART RING
• Patient Outcome(s): Required Intervention; Hospitalization; Death
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 121 KG