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 2020-02-20 for SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) 500101-001 500101 manufactured by Syncardia Systems, Llc.
[180150591]
A syncardia clinical expert provided the following summary of events and clinical conclusion: summary of events: the patient was implanted with the 70cc tah-t on (b)(6) 2019. Prior to tah-t implant a head ct was obtained that revealed evidence of a small ischemic event. Of note, the patient required ecmo pre-implant. On or around (b)(6) 2020, the patient spiked a fever and was treated with antibiotics. Prior to this time, his inr had been stable at a level of approximately 2. 5 on 4mg of coumadin. On (b)(6) 2020, the inr peaked at 6. 24 which significantly increased the patient's risk of bleeding and may have been associated with the administration of antibiotics. Changes in the patient's neurological status were noted around the time that the patient spiked a fever. Neurology was consulted and determined the patient was having seizures. The patient was treated, and some improvement was noted. On (b)(6) 2020, the patient's neurological status was significantly worse, and he became nonresponsive. A ct scan was completed and revealed a hemorrhagic stroke which subsequently led to his death on (b)(6) 2020. Clinical conclusion: the events summarized above indicate that the most likely cause of the hemorrhagic stroke was the sharp increase in inr (anticoagulation) and may have been associated with the administration of antibiotics to treat the presumed infection. The timeline suggests that the cerebral bleeding may have started around (b)(6) 2020 and increased in severity over time as evidenced by the noted neurological changes which increased in severity. The tah-t does not appear to have caused or contributed to the hemorrhagic stroke and subsequent death of the subject. 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. 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. Ce 5172 initial.
Patient Sequence No: 1, Text Type: N, H10
[180150592]
The customer, a syncardia certified hospital, reported that the patient passed away on (b)(6) 2020. The customer reported the patient had an external brain stem bleed and that neurosurgery was unable to treat the patient. The customer also reported that the team discussed withdrawal of patient support. The customer reported the cause of death as intracerebral hemorrhage. The customer also reported that the tah-t was not explanted. No further information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00036 |
| MDR Report Key | 9732504 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2020-02-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 5451234120 |
| Manufacturer G1 | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON, AZ |
| Manufacturer Country | US |
| 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 | 2020-02-20 |
| Model Number | 500101-001 |
| Catalog Number | 500101 |
| Lot Number | 110967 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-20 |