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

Catalog Number	P/N 500101
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The removed section of driveline will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
Event or Problem Description
The customer, a syncardia authorized distributor, reported that the patient observed air leaking from a cannula.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that the 70cc tah lot # 123283 was manufactured up to specifications and no anomalies were found.The provided photographic evidence showed a cannula tear near the distal end of the cpc connector barb.The tear was circumferential and spanned approximately 25% of the cannula.No functional testing is possible as the cannula continued to be in patient use after repair and no additional testing was needed as the tear was visible from the photographs.The reported leak was resolved after the tear was fixed with rescue tape.Failure investigation for this complaint confirmed the reported issue from examining the provided photographic evidence.The customer complaint was not replicated as the device was not returned; the root cause of the reported leak was determined to be a cannula tear.The cause of the cannula tear cannot be determined; however, historical investigations have identified the driveline/cannula junction as a point of increased stress.This is a known issue that is currently being addressed in capa-2022-0007.Failure investigation identified no other test failures or damage that could have contributed to the event.The cannula tear was repaired immediately per the provided instruction and 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.
Event or Problem Description
The customer, a syncardia authorized distributor, reported that the patient observed air leaking from a cannula.

• Brand Name: SYNCARDIA 70CC TEMPORARY 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: 16943189
• Report Number: 3003761017-2023-00072
• Device Sequence Number: 15182475
• 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: 2021
• 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): 04/22/2025

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: 01/31/2024
• Device Catalogue Number: P/N 500101
• Device Lot Number: 123283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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: 31 YR
• Patient Sex: Male