MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TOTAL ARTIFICIAL HEART (STAH); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number	P/N 500101
Medical Device Problem Codes	Leak/Splash (1354); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been received for explant analysis at the time of this report but will be evaluated immediately upon return.
Event or Problem Description
Per the implanting hospital staff, the patient was initially implanted with right and left ventricles from tah-t kit (sn: (b)(6), device was turned on, bypass turned off.Surgeon noted blood "leaking" from right ventricle.Blood noted to be coming out of right ventricle near the inflow connector/valve.Patient placed back on bypass, tah turned off.Right ventricle (id: 128758r0823) removed from patient.New implant kit obtained (sn: (b)(6) and new right ventricle (id: 128924r0923) implanted.Patient was ultimately successfully implanted after being placed back on bypass, then replacement ventricle was implanted and patient taken off bypass, fully supported on the tah.No other adverse impact to patient was reported.
Event or Problem Description
Per the implanting hospital staff, the patient was initially implanted with right and left ventricles from tah-t kit (sn: (b)(6)), device was turned on, bypass turned off.Surgeon noted blood "leaking" from right ventricle.Blood noted to be coming out of right ventricle near the inflow connector/valve.Patient placed back on bypass, tah turned off.Right ventricle (id (b)(6)) removed from patient.New implant kit obtained (sn (b)(6)) and new right ventricle ( id: (b)(6)) implanted.Patient was ultimately successfully implanted after being placed back on bypass, then replacement ventricle was implanted and patient taken off bypass, fully supported on the tah.No other adverse impact to patient was reported.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that stah lot number: 130338 (right ventricle id: (b)(6)) was serviced and passed all functional testing prior to being released to finished goods on 02 apr 2025.Visual inspection of device found no abnormalities around the inflow valve, inflow quick connect, and outer sleeve.An air bubble was found around the junction area between the quick connect outer sleeve for outflow valve but was not of significance and did not affect the functionality of the device.The right stah ventricle passed all functional testing during initial explant analysis.A non-clinical inflow connector was utilized to test latching ability to inflow outer sleeve, and for leaks when running water from a faucet into the connector.Inflow connector was able to be attached without issues and kept a firm grip on inflow outer sleeve.With inflow connector attached, water flowed vertically onto junction between inflow valve and inflow outer sleeve at different angles.No water drops or leaks could be detected at any junction.Right ventricle was submerged in water on stroke volume test fixture to test for leaks with increasing pressure from a hand pump.The inflow and outflow outer sleeve were covered.Cannula was attached to center hole from the underside of stroke volume test fixture's lid and submerged right ventricle.No air bubbles were detected, indicating no leaks.Still underwater and connected to nozzle of lid, right ventricle was air pressurized by hand pump through the nozzle on the top side of stroke volume test fixture's lid.While actuating hand pump, no air bubbles were detected, indicating no leaks.Right ventricle was connected to dmc tank and c2 driver under normotensive conditions.No leaks were detected, right average cardiac output was within specifications, and pressure outputs remained normotensive.Failure investigation for this complaint could not confirm the reported issue.The customer complaint was not replicated; the root cause of the reported leaking right stah ventricle could not be determined.Failure investigation identified no test failures or damage that could have contributed to the event.The air bubble found at the junction of the outflow connector and the ventricle was cosmetic only.No evidence of a device malfunction was found and the stah functioned as intended.The patient was placed back on bypass support and then implanted with a replacement right ventricle.No adverse impact to patient reported.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.

• Brand Name: SYNCARDIA 70CC TOTAL ARTIFICIAL HEART (STAH)
• Common Device Name: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer Contact: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 22379036
• Report Number: 3003761017-2025-00120
• Device Sequence Number: 20972481
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008(10)130338(11)240221(17)270331
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: P/N 500101
• Device Lot Number: 130338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male