MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

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

Patient Problems Bacterial Infection (1735); Encephalopathy (1833); Hemolysis (1886); Hemorrhage/Bleeding (1888); Liver Damage/Dysfunction (1954); Renal Failure (2041); Urinary Tract Infection (2120); Viral Infection (2248); Renal Impairment (4499); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

The syncardia 70cc temporary total artificial heart (tah-t) is an implantable pulsatile biventricular replacement device that replaces a patient's native ventricles and valves and pumps blood to both the pulmonary and systemic circulation systems.The syncardia 70cc tah-t is indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.The syncardia tah-t system is intended for use inside and outside the hospital.Investigation summary: intermacs patient registry data collected from (b)(6) 2017 through (b)(6) 2018 regarding adverse events was reviewed.Patients were de-identified therefore a one-to-one correlation could not be made between the patient and the lot number of the implanted tah-t.With a review of the available information, there is no evidence of a device malfunction or performance issues that would impact the reported events.Possible clinical factors that may have contributed to these events include the patients pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulants, antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to these events.This device is used for treatment, not diagnosis.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4), (b)(6) initial.

Event Description

While supported by a tah-t, the patient has experienced the following adverse events as defined by intermacs: 10 days post implant - renal dysfunction.18 days post implant - bleeding.18 days post implant - pericardial drainage.53 days post implant - hepatic dysfunction.93 days post implant - infection i location: other i type: bacterial.218 days post implant - bleeding.218 days post implant - infection i location: positive blood cultures, pulmonary i type: bacterial.218 days post implant - other sae.244 days post implant - infection i location: positive blood cultures i type: viral.298 days post implant - infection i location: positive blood cultures i type: bacterial.As of (b)(6) 2018 it was reported that the patient was still supported by a tah-t.

Event Description

Since the last reporting period, the patient experienced the following adverse events as defined by intermacs: 393 days post implant - device malfunction and/or pump thrombosis.399 days post implant - device malfunction and/or pump thrombosis.543 days post implant - device malfunction and/or pump thrombosis.As of (b)(6) 2019 it was reported that the patient was still supported by a tah-t.

Manufacturer Narrative

Additional information has been provided in section b5.Intermacs patient registry data collected from january 1, 2019 through june 30, 2019 regarding adverse events was reviewed.Patients were de-identified therefore a one-to-one correlation could not be made between the patient and the lot number of the implanted tah-t.Ce 5076, pt (b)(6), follow-up report 1.

Event Description

Since the last reporting period, the patient experienced the following adverse events as defined by intermacs: 693 days post implant - bleeding.701 days post implant - renal dysfunction.704 days post implant - infection i location positive blood cultures, urinary tract i type: bacterial.728 days post implant - neurological dysfunction - encephalopathy.810 days post implant - bleeding.816 days post implant - infection i location positive blood cultures, pulmonary i type: bacterial.As of september 30, 2020 it was reported that the patient was still supported by a tah-t.

Manufacturer Narrative

Intermacs patient registry data collected from july 1, 2019 through september 30, 2020 regarding adverse events was reviewed.Patients were de-identified therefore a one-to-one correlation could not be made between the patient and the lot number of the inmplanted tah-t.(b)(4) pt (b)(6) follow-up report 2.

Manufacturer Narrative

Intermacs patient registry data collected from (b)(6) 2021 through (b)(6) 2022 regarding adverse events was reviewed.Patients were de-identified therefore a one-to-one correlation could not be made between the patient and the lot number of the implanted tah-t.(b)(4) pt (b)(6) (di_202) follow-up report 3.

Event Description

During the last reporting period, it was reported that the patient had experienced the following adverse events as defined by intermacs.4 days post implant - hemolysis, 4 days post implant - right heart failure, 32 days post implant - hemolysis, 96 days post implant - hemolysis, 200 days post implant - hemolysis, 369 days post implant - hemolysis, 547 days post implant - hemolysis, 732 days post implant - hemolysis.As of (b)(6) 2022, it was reported that the patient was still supported by the tah-t.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 8599539
• MDR Text Key: 144716086
• Report Number: 3003761017-2019-00141
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 500101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2022
• 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): Other
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White