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); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041); No Code Available (3191); Liver Failure (4492)

Event Type  Death  

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 between april 1, 2014 and september 30, 2017 regarding adverse events was retrospectively 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.These events were assessed and are being reported in response to an update to the mdr complaint sources.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).

Event Description

While supported by the tah-t, the patient has experienced the following adverse events as defined by intermacs: 0 day post implant - bleeding; 92 days post implant - infection/location: other/type: bacterial; 140 days post implant - device malfunction and/or pump thrombosis; 138 days post implant - device malfunction and/or pump thrombosis; 153 days post implant - device malfunction and/or pump thrombosis; 175 days post implant - device malfunction and/or pump thrombosis; 219 days post implant - device malfunction and/or pump thrombosis; 197 days post implant - infection/location: pump/related - drive line, pump/related - pump pocket, pump/related - pump interior, mediastinum/type: bacterial.As of (b)(6) 2017 it was reported that the patient was still supported by the tah-t.

Manufacturer Narrative

Additional information has been provided.Intermacs patient registry data collected from october 1, 2017 through december 31, 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.(b)(4) pt (b)(6) follow-up report 1.

Event Description

Since the last reporting period, the patient experienced the following adverse event as defined by intermacs: 444 days post implant - device malfunction and/or pump thrombosis.As of december 31, 2018 it was reported that the patient was still supported by the 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.

Event Description

Since the last reporting period, the patient experienced the following adverse event as defined by intermacs: 1348 days post implant - bleeding.As of september 30, 2020 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: 1393 days post implant - infection | location pulmonary | type: bacterial.1412 days post implant - neurological dysfunction | cva - location: other | severity: left sided weakness.1514 days post implant - bleeding.As of (b)(6) 2021, it was reported that the patient was still supported by a tah-t.

Manufacturer Narrative

Intermacs patient registry data collected from october 1, 2020 through march 31, 2021 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).

Manufacturer Narrative

Additional information has been provided in section b2, b5 and h6.Intermacs patient registry data collected from (b)(6), 2021 through (b)(6), 2021 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) follow-up report 4.

Event Description

Since the last reporting period, the patient experienced the following adverse events as defined by intermacs: 1536 days post implant - other sae.1569 days post implant - renal dysfunction.1584 days post implant - infection | location = pump/related - drive line, positive blood cultures | type: bacterial.1633 days post implant - infection | location = positive blood cultures | type: bacterial.1680 days post implant - bleeding.1681 days post implant - renal dysfunction.1693 days post implant - hepatic dysfunction.The patient subsequently expired with no cause of death listed after 1870 days of tah-t support.

• 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: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 7731454
• MDR Text Key: 115390349
• Report Number: 3003761017-2018-00396
• 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,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 500101
• Date Manufacturer Received: 12/08/2021
• 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; Death
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American