MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Cardiomyopathy (1764); Death (1802); Neurological Deficit/Dysfunction (1982)

Event Type  Death  

Manufacturer Narrative

Investigation summary: 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 this event 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 this event.This device is used for treatment, not diagnosis.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.This event was assessed and is being reported as part of a retrospective review of events in response to an update to the mdr complaint sources.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4).

Event Description

A retrospective review of intermacs de-identified data collected between september 22, 2015 and september 30, 2017 revealed that a patient expired with a cause of death listed as circulatory: end stage cardiomyopathy.The intermacs data listed that the tah-t functioned normally.The intermacs data listed that the tah-t was not explanted.

Manufacturer Narrative

(b)(6).

Event Description

While supported by the tah-t for 11 days, the patient experienced the following adverse events as defined by intermacs: at 1 day post implant - neurological dysfunction - cva/location: other, right hemisphere: frontal, right hemisphere: occipital, right hemisphere: parietal, right hemisphere: temporal/severity: left sided weakness; 8 days post implant - bleeding.

• Brand Name: SYNCARDIA 70CC TAH-T
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 7468876
• MDR Text Key: 106757453
• Report Number: 3003761017-2018-00186
• 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: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 500101
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2017
• 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): Death
• Patient Weight: 110