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

Model Number 500101-001

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the cannula tear did not prevent the tah-t system from performing its life-sustaining function.The damaged section of the 70cc tah-t cannula was repaired by the hospital staff and remains on the patient; therefore no piece of cannula will be returned to syncardia for evaluation.Syncardia will conduct a review of the tah-t device history record (dhr) and previous occurrences of cannula tears.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the left cannula of the 70cc tah-t had a tear.The customer also reported that the 70cc tah-t cannula was successfully repaired with rescue tape by the hospital staff.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.

Manufacturer Narrative

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.The hospital provided a picture of the left cannulae which shows a tear at the end of the internal metal reinforcing wire closest to the cpc connector; part of the interior wire was exposed in the tear.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 tear 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 tear was corrected at the hospital with tape and the patient was successfully transplanted on (b)(6), 2019.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.Ce 4552 follow-up report 1.

• 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
• MDR Report Key: 8113016
• MDR Text Key: 129347378
• Report Number: 3003761017-2018-00530
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 094327
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR