MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problems Crack (1135); Leak/Splash (1354); Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015, the customer reported that the patient detected a leak on the right 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 patient.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 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

On (b)(6) 2015, the customer reported that the patient detected a leak on the right 70cc tah-t cannula that was connected to his freedom driver.The customer also reported that the 70cc tah-t cannula was successfully repaired by the patient.At the time of the reported cannula tear, the patient had been on tah-t support for 1,585 days.The piece of cannula that was removed during the repair was returned to syncardia for evaluation.Visual inspection revealed that the cannula material was slightly discolored and had increased stiffness.A breach was observed in the area in contact with the end of the cpc connector.When pressure was applied to the cannula section using fingertips, it was observed that the breach completely penetrated the cannula wall.There were wear marks on the material in the area surrounding the crack, indicating that the tear initiation and eventual penetration did not occur quickly, but over time.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.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair, and there were no reports of additional cannula tears for this patient.There were (b)(4) worldwide implants between 2004 and february 12, 2016.Cumulative cannula tears during this interval were (b)(4).Based on two opportunities for cannula tear per implanted tah-t, the rate of occurrence during this interval is (b)(4).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 / preventive action) to address and document root cause and corrective actions associated with cannula tears.Corrective actions for this failure mode are being evaluated under the capa.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA 70CC 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: 5289528
• MDR Text Key: 33906314
• Report Number: 3003761017-2015-00420
• 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: 12/02/2015

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: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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: 43 YR