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.
[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
| Report Number | 3003761017-2020-00050 |
| MDR Report Key | 9676743 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| 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 | 2020-02-06 |
| Catalog Number | 500101 |
| Lot Number | 108284 |
| Device Expiration Date | 2020-01-31 |
| 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. Other | 2020-02-06 |