MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICAL HEAR (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Model Number 500101-001

Device Problem Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2020

Event Type  malfunction  

Manufacturer Narrative

The cannula piece with the air leak/tear was not retained by the hospital.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the patient observed an air leak/tear in the 70cc tah-t cannula.The customer also reported that the 70cc tah-t cannula was successfully repaired.There was no reportable adverse patient impact as a result of the cannula tear and subsequent repair.

Manufacturer Narrative

The removed cannulae pieces were not returned to syncardia, as they were not retained by the hospital.A visual inspection of the cannulae was performed from images provided by the hospital.A tear can be seen in the photograph of the removed section of right cannula confirming the customer-reported tear.There are multiple contributing causes of cannula tears.As identified in previous cannula tear investigations, patients supported by portable drivers are more likely to place increased stress on the cannulae.These stresses are concentrated where the effective stiffness of the cannula changes, specifically at the velour/cannula junction and the driveline/cannula junction.Increased stresses are caused by the different material behaviors of the pvc cannula material, the stainless-steel reinforcing wire, the cpc connector, wire ties, and the cannula velour leading to tear initiation.Additionally, material stability may play a role in cannula mechanical failure.Mechanical performance of pvc is negatively affected by aging.Over time, plasticizer leaches/evaporates out of the pvc material, reducing the flexibility and elasticity of the material and leading to failure.The above factors could have contributed to the cannula tear.Moreover, the patient's length of time being supported by a portable driver may have increased the likelihood of cannula tear due to increased stresses.Syncardia has a corrective and preventive action plan (capa) to address preventive actions for cannula tears.Syncardia has completed its investigation and is closing this file.Ce 5340 follow-up report 1.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICAL HEAR (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 10502771
• MDR Text Key: 206166336
• Report Number: 3003761017-2020-00176
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 119223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR