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

Model Number 500101-001

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

The alleged failure modes pose a low risk to the patient because the cannula tear and discoloration did not prevent the tah-t system from performing its life-sustaining function.The damaged sections of the 70cc tah-t left and right cannulae were not retained by the hospital staff; therefore no pieces of cannula were returned to syncardia for evaluation and the tah-t remains implanted.Review of the device history record, both base/cannula shop orders, the incoming inspection logs, and the sterilization work order found no anomalies.All manufacturing was performed to specifications.The tah-t met all specified requirements prior to shipment.Cannula tears: the hospital indicated that the tears in the left and right cannula were in approximately the same location about 3 cm above the connector.As identified in previous cannula tear investigations, patients supported by a portable driver are more likely to place increased stresses on the cannulae.These stresses are concentrated where the effective stiffness of the cannula changes, specifically at the velour/cannula junction or the driveline/cannula junction.The increased stresses at these junctions can lead to a cannula tear.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 tears reported by the customer.Moreover, the patient's length of time being supported by a portable driver allows more opportunities for stresses on the cannulae that may lead to a cannula tear.The cannula tears were corrected at the hospital by cutting out the torn pieces of cannula above the connector and re-inserting a new connector to the cut ends on both cannulae.Syncardia has a corrective and preventive action (capa) to address preventive actions for cannula tears.Cannula discoloration no visual evidence was provided by the customer to confirm the reported discolored cannulae.It is likely that the darkening of the cannulae resulted from exposure to environmental factors in the patient's surroundings or from the age of the material.This pattern is consistent with previously-reported instances of darkened cannula.The root cause of the darkened cannulae cannot be conclusively determined, but appears to be consistent with the cannulae discoloration investigated in previously with other patients.The freedom driver system operator manual (f-900012-de) and the freedom driver system guidebook for patients and caregivers (f-900015-de) instruct patients to examine their cannulae regularly and to not use cleaners on the drivelines, cannulae, drivers or driver accessories.Users are to use extreme care when cleaning the freedom driver and drivelines, and to wipe the drivelines gently with a soft, clean cloth lightly dampened only with water.These issues will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the patient and caregiver heard an air leaking sound which subsequently lead to the identification of a tear in approximately the same location on both the left and right cannula of the 70cc tah-t.The customer also reported that the cannulae were discolored but pliable.The customer also reported that the hospital successfully repaired both the left and right 70cc tah-t cannulae by cutting out the torn piece of cannula above the connector and re-inserting a new connector to the cut end on both cannulae.There was no reported adverse patient impact as a result of the cannulae tears and subsequent repairs.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 8480316
• MDR Text Key: 141959294
• Report Number: 3003761017-2019-00056
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• 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
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 107691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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: 51 YR