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 Blurred Vision (2137); Patient Problem/Medical Problem (2688)

Event Date 01/13/2020

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.The tah-t remains implanted.Based on the provided information there is no evidence to indicate any device malfunctions or performance issues of the device that would impact the reported event.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that on (b)(6) 2020, following the placement of a j tube, patient complained of changes in vision.Per the neurology consult, on exam, patient with clear left homonymous hemianopia, but also complained of generally blurred vision.Administration of the nihss resulted in a score of 2 because of left homonymous hemianopia.The standard mrs score on the day of the event was a 3 and the mrs stroke-related score was a 3.The ct report indicated a questionable subtle focus of hypo attenuation and loss of gray-white differentiation in the right occipital lobe which could represent acute ischemia, given the subject's symptoms.The patient had a pre-tah-t implant baseline standard modified rankin scale (mrs) score of 3 and a stroke-related mrs score of 0 on (b)(6) 2019.Her baseline nihss score of 2 was recorded on (b)(6) 2019.The customer also reported that on (b)(6) 2020, a 9mm aneurism had been discovered on the patient's head ce scan and no plan of action had been determined for this situation.The patient's vision remained blurred centrally, decreased peripheral vision, central vision seems to be improving.The customer also reported that on (b)(6) 2020, the patient had a standard mrs score of 3, a stroke-related mrs score of 1, and a nihss score of 3.

• 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 Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 9676743
• MDR Text Key: 177998673
• Report Number: 3003761017-2020-00050
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 500101
• Device Lot Number: 108284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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): Other
• Patient Age: 40 YR