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 2020-02-21 for SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) 500101-001 500101 manufactured by Syncardia Systems, Llc.
[180422943]
Additional information requested from the hospital is provided below: what was the international normalized ratio (inr) at the time of the event? Inr was 3. 4. What was the anticoagulant regimen at the time of the event? Coumadin. Did the patient have a history of ischemic or hemorrhagic stroke prior to the event? No. A syncardia clinical expert reviewed the information on the reported event and concluded the following. The patient did not have a history of stroke. The patient's inr was 3. 4 at the time of the hemorrhagic stroke. The elevated inr may have contributed to the event. 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. (b)(4) initial
Patient Sequence No: 1, Text Type: N, H10
[180422944]
The customer, a syncardia certified hospital, reported that the patient passed away on (b)(6) 2020. The customer reported the patient experienced a catastrophic neurological event (hemorrhagic stroke) and expired. The customer reported the cause of death as brain death and indicated that the tah-t did not cause or contribute to the patient's outcome. The customer also reported that the tah-t was not explanted and that no autopsy was performed. No further information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00059 |
| MDR Report Key | 9741967 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2020-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2020-02-21 |
| Model Number | 500101-001 |
| Catalog Number | 500101 |
| Lot Number | 117779 |
| 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 | 2020-02-21 |