MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial.

Event Description

The customer reported that the patient was taken to the hospital when the patient noticed there was a small tear on the 70cc tah-t cannula that is connected to a freedom driver.The customer also reported that the 70cc tah-t cannula was successfully repaired by the hospital staff.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.This alleged failure mode poses a low risk to the patient because although there was a small tear on the tah-t cannula, the freedom driver continued to perform its life-sustaining functions.Syncardia has initiated a capa (corrective or preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.The removed tah-t cannula piece will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).This is not a single use device that was reprocessed and reused on a patient.

Event Description

The customer reported that the patient was taken to the hospital when the patient noticed there was a small tear on the 70cc tah-t cannula that was connected to a freedom driver.The customer also reported that the 70cc tah-t cannula was successfully repaired by the hospital staff.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.At the time of the reported cannula tear, the patient had been on tah-t support for 331 days.The section of cannula that was removed during the repair was returned to syncardia for evaluation.Visual inspection revealed that the cannula section was slightly yellowed, likely because of age, and had a tear near where the velour would have been.The tear went through all layers of the cannula.There were no other tears identified on any other section of the cannula.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.The increased stresses at these junctions can lead to a cannula tear.This is caused by the different material behaviors of the pvc cannula material, the stainless steel reinforcing wire, the cpc connector and the cannula velour when placed under flexural, rotational or tensile stresses.Wear occurs at the surface or between pvc layers, eventually leading to tear initiation.The patient was successfully transplanted on (b)(6) 2016.There were 1,090 worldwide implants between 2004 and february 12, 2016.Cumulative cannula tears during this interval were (b)(6).Based on two opportunities for cannula tear per implanted tah-t, the rate of occurrence during this interval is (b)(6).This failure mode poses a low risk to the patient because although there was a small tear on the tah-t cannula, the tah-t system with the freedom driver continued to perform its life-sustaining functions.Syncardia has initiated a capa (corrective or preventive action) to address and document root cause and corrective actions associated with cannula tears.Corrective actions for this failure mode is being evaluated under the capa.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5396339
• MDR Text Key: 37432578
• Report Number: 3003761017-2016-00032
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/23/2016

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 500101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2016
• Initial Date FDA Received: 01/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR