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 Hemolysis (1886); Unspecified Infection (1930); Viral Infection (2248); Respiratory Failure (2484); Thrombosis/Thrombus (4440); Renal Impairment (4499)

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) 2019 through (b)(6) 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 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.(b)(4).

Event Description

While supported by thetah-t, the patient has experienced the following adverse events as defined by intermacs: 3 days post implant - renal dysfunction.As of (b)(6) 2020 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.Ce 5660 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: 113 days post implant: device malfunction and/or pump thrombosis.113 days post implant: respiratory failure.123 days post implant: device malfunction and/or pump thrombosis.127 days post implant: infection | location unknown | type: viral.As of on (b)(6) 2021, it was reported that the patient was still supported by a tah-t.

Event Description

During the last reporting period, it was reported that the patient had experienced the following adverse event as defined by intermacs: 72 days post implant - device malfunction and/or pump thrombosis.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 (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 2.

Manufacturer Narrative

Intermacs patient registry data collected from july 1, 2021 through march 31, 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_70) 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.7 days post implant - hemolysis.36 days post implant - hemolysis.92 days post implant - hemolysis.189 days post implant - hemolysis.247 days post implant - infection| location other | type: unk.295 days post implant - renal dysfunction.306 days post implant - device malfunction and/or pump thrombosis.The patient subsequently received a heart transplant after 363 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: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 11760916
• MDR Text Key: 248563375
• Report Number: 3003761017-2021-00072
• 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
• 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: 05/03/2021
• 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: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American