MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-11 for SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) 500101-001 500101 manufactured by Syncardia Systems, Llc.
[178543142]
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 was not explanted, therefore it was not returned to syncardia for evaluation. 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. A definitive root cause cannot be conclusively determined. 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) initial.
Patient Sequence No: 1, Text Type: N, H10
[178543143]
The customer, a syncardia authorized distributor, reported that the patient passed away on (b)(6) 2020. The customer reported the cause of death as multi-organ failure and that the tah-t did not cause or contribute to the death of the patient. The customer also reported that the tah-t was not explanted and no autopsy was performed. No additional information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00062 |
| MDR Report Key | 9693338 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KERRI HENSLEY |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON AZ 85713 |
| Manufacturer Country | US |
| Manufacturer Postal | 85713 |
| Manufacturer Phone | 5205451234 |
| Manufacturer G1 | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON AZ 85713 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85713 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) |
| Generic Name | BIVENTRICULAR REPLACEMENT DEVICE |
| Product Code | LOZ |
| Date Received | 2020-02-11 |
| Model Number | 500101-001 |
| Catalog Number | 500101 |
| Lot Number | 117476 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Address | 1992 E. SILVERLAKE ROAD TUCSON AZ 85713 US 85713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-11 |