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

Catalog Number	P/N 500101
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event constitutes the first serious adverse event related to the existing open recall, recall number: z-1022-2023, regarding cannula tears.This is the second event for the same patient under the open recall and associated capa, capa-2022-0007.Updated information will be provided to update the capa and open recall and an assessment for potential changes to safety and effectiveness will be completed.Appropriate action will take place when all assessments and updates have been reported.A supplemental report to this mdr will be provided as the information becomes available.
Event or Problem Description
Per distributor, the patient's cannula broke for the second time.The first cannula tear occurred on (b)(6) 2023, two years prior.On this occasion, the patient temporarily taped it at home, and then in the hospital they barely managed to fix the cannula by inserting a piece of driveline cpc connector.Patient is being held in the hospital until a decision is made on how to fix or replace the ventricle.No serious injury to the patient occurred, however, a prolonged hospital stay is expected as the intervention required is not readily accessible.

• 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: 23885111
• Report Number: 3003761017-2025-00190
• Device Sequence Number: 4771505
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: Lay User/Patient
• Device Catalogue Number: P/N 500101
• Device Lot Number: 123283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1022-2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 33 YR
• Patient Sex: Male