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

Catalog Number	P/N 500101
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per the hospital staff, patient called mcs coordinator reporting not feeling well, could hear and feel air hissing from red cannula of tah.Patients wife successfully taped the red cannula.Patient brought into clinic, crack on red cannula end of cpc connector.Cannula was cut proximal to crack and patient changed onto new freedom driver.In order to facilitate an easier transition to the repaired cannula, the hospital staff determined switching the patient to a backup driver would be quicker and easier.The cut segment of cannula that was removed during the repair was returned with the initial freedom driver, however, no complaint was made against the driver for this complaint.The freedom driver had functioned as intended.No issues with the cpc connector were reported, the changeout went smoothly without any adverse impact to patient.Crack was reported to be on the patient end of the cannula.No adverse impact to patient reported.
Additional Manufacturer Narrative
Device history report (dhr) review for 70cc tah-t, lot# 130347 was performed and no anomalies were found and all manufacturing was performed to specifications.Upon examination of the right cannula piece, it was noted that the cannula piece had a tear near the distal end of the cpc connector barb.The tear was circumferential where it spanned approximately 25% around the circumference of the cannula.The root cause of the patient-reported issue of a leak in the cannula is due to a tear.This tear is likely the crack seen and reported by the customer.The root cause of the tear is most likely caused by increased stresses which could lead to material degradation.Cannula tears are a known issue that is currently being addressed via a corrective and preventive capa for cannula tears.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.
Event or Problem Description
Per the hospital staff, patient called mcs coordinator reporting not feeling well, could hear and feel air hissing from red cannula of tah.Patients wife successfully taped the red cannula.Patient brought into clinic, crack on red cannula end of cpc connector.Cannula was cut proximal to crack and patient changed onto new freedom driver.In order to facilitate an easier transition to the repaired cannula, the hospital staff determined switching the patient to a backup driver would be quicker and easier.The cut segment of cannula that was removed during the repair was returned with the initial freedom driver, however, no complaint was made against the driver for this complaint.The freedom driver had functioned as intended.No issues with the cpc connector were reported, the changeout went smoothly without any adverse impact to patient.Crack was reported to be on the patient end of the cannula.No adverse impact to patient reported.

• Brand Name: SYNCARDIA TOTAL ARTIFICIAL HEART (STAH) 70CC
• 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: 22853846
• Report Number: 3003761017-2025-00128
• Device Sequence Number: 19955298
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• 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
• 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): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: P/N 500101
• Device Lot Number: 130451
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 35 YR
• Patient Sex: Male