MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TOTAL ARTIFICIAL HEART; 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	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the section of damaged cannula is removed and replaced, it has been ask to be returned to syncardia for evaluation.Those results will be provided in a follow-up mdr.
Event or Problem Description
The customer, a syncardia authorized distributor, reported that the patient had a tear on one cannula line.The cannula was reviewed by clinical support to be a single thickness tear, and there was no air leaking from the cannula.Clinical support sent sections of cannula to the distributor for them to evaluate a possible replacement of the torn section of cannula.
Event or Problem Description
The customer, a syncardia authorized distributor, reported that the patient had a tear on one cannula line.The cannula was reviewed by clinical support to be a single thickness tear, and there was no air leaking from the cannula.Clinical support sent sections of cannula to the distributor for them to evaluate a possible replacement of the torn section of cannula.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that no anomalies were found and all manufacturing was performed to specifications.Visual inspection of external components found a tear located beyond the velour fabric and was circumferential where it spanned approximately 50%, around the cannula.Functional testing could not be performed as the cannula was not returned as it was still in use.Visual inspection confirmed the tear from photographic evidence provided with the complaint.Failure investigation for this complaint confirmed the reported issue from the photographic evidence provided in the complaint.The customer complaint was not replicated; the root cause of the cannula tear could not be conclusively determined, however, it was likely due to increased mobility and increased stress time on the material.Failure investigation identified no other test failures or damage that could have contributed to the event.Cannula tears/fractures are currently being addressed.The tear was repaired immediately and patient followed up with hospital staff to ensure no further issues were found with the cannula.No adverse impact to the patient was 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
• 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
• MDR Report Key: 16743357
• Report Number: 3003761017-2023-00044
• Device Sequence Number: 12422577
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (Y/N): N
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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 Expiration Date: 03/25/2025
• Device Catalogue Number: P/N 500101
• Device Lot Number: 125574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male