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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

The removed cannulae have been sent to syncardia for evaluation.The results will be provided in a follow-up mdr.Ce 5420 initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient presented in the emergency department with a leak in the right ventricular cannula approximately 7 cm from the cpc disconnect fitting (mfr report 3003761017-2020-00245).This cannula appeared to have gotten darker in color.The cannula appeared to have several spots where appearances of stresses have occurred.The cannula had a harder texture and did not feel to be as pliable since the last time mcs specialist saw him.It appears that the right ventricular cannula may have expanded or maybe delaminated on the inside (mfr report 3003761017-2020-00244).There was no reported adverse patient impact.The customer also reported that cannula was cleaned, a clear self-sealing silicon tape was applied to the leak site extending 2.5 cm to the sides of the hole.Three nylon cable ties were placed on the site to keep pressure on the self-sealing silicon tape to ensure a tight seal.Clear silicon tape was then placed over the nylon cable ties to protect the patient's skin.Both the right and the left cannulae were taped together to better support each other.The customer also reported that 5 days later, both the left and right damaged cannula were cut and spliced with new cannulae.

Manufacturer Narrative

Syncardia closed a corrective and preventive action (capa) capa-0228, tah-t cannula holes / tears, to address the issue of cannula tears.From the results of the capa investigation, the primary root cause for cannula breaches is attributed to usability on a portable driver.The failure investigation found that all patients experiencing a cannula breach have been supported by a portable driver.Patients on a portable driver are more likely to place increased stress on the cannula.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 breach.This is due to the different material behaviors of the pvc cannula material, the stainless-steel reinforcing wire and the cpc connector when placed under flexural, rotational or tensile stresses.Wear occurs at the surface or between pvc layers, eventually leading to tear initiation and breach.The previous capa (capa-0228) determined an appropriate correction but did not identify a preventive action.Therefore, a second capa, syncardia capa-0270, preventive capa for cannula, was opened to address preventive actions and is currently at step 5 action plan.Syncardia has completed its evaluation and is closing this file.Ce 5420 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: 10945183
• MDR Text Key: 219547435
• Report Number: 3003761017-2020-00245
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR