SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) 500101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-06 for SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) 500101 manufactured by Syncardia Systems, Llc.

Event Text Entries

[177998673] 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).
Patient Sequence No: 1, Text Type: N, H10


[177998714] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003761017-2020-00050
MDR Report Key9676743
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-06
Date of Report2020-02-05
Date of Event2020-01-13
Date Mfgr Received2020-01-14
Device Manufacturer Date2017-01-01
Date Added to Maude2020-02-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KERRI HENSLEY
Manufacturer Street1992 E. SILVERLAKE ROAD
Manufacturer CityTUCSON AZ 85713
Manufacturer CountryUS
Manufacturer Postal85713
Manufacturer Phone5205451234
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
Generic NameBIVENTRICULAR REPLACEMENT DEVICE
Product CodeLOZ
Date Received2020-02-06
Catalog Number500101
Lot Number108284
Device Expiration Date2020-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYNCARDIA SYSTEMS, LLC
Manufacturer Address1992 E. SILVERLAKE ROAD TUCSON AZ 85713 US 85713


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-06

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