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

Catalog Number 500101

Device Problems Crack (1135); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2022

Event Type  malfunction  

Event Description

The customer, a syncardia certified hospital, reported that the patient telephoned the on-call emergency mcs coordinator to report an air leak to his tah-t cannula.(the patient has been supported by the tah-t for 322 days.) the mcs coordinator told the patient to reinforce the leaking area with tape and to present to the emergency department (ed).The patient¿s physicians were notified.The patient arrived to the ed via private vehicle; he walked in, was awake, alert and asymptomatic.The patient was met in the ed by a mcs coordinator and ct surgeon.The customer reported that there was a noticeable audible and visual leak (red rescue tape pulsing with beat of tah).The cannula tear was noted to be just above zip tie connection underneath black electrical tape on cpc connector of the red cannula.The backup freedom driver was turned on and readied.The ct surgeon then cut the cannula proximal to the tear, backup driver with new cpc connector then connected without difficulty.The other cannula (blue) connection changed via normal procedure with cpc connection.New zip ties were applied to cpc connectors and to the red cannula and secured with banding gun.The patient¿s physicians were notified of procedure completion and the patient was discharged from the ed.Additional information provided by the customer during a telephone call with syncardia: patient discovered the tear by hearing the air leak.Hospital applies rescue tape to the cannulae prior to discharge.With wear and tear, the rescue tape comes off the distal end, exposing the segment closest to the cpc connector.The tear was discovered near the cpc connector by patient.Black electrical tape was used to wrap around the tear.The combination of the black electric tape and red rescue tape allowed the air to enter in between the tape and cannula and create a pulsatile movement.Patient felt lightheadedness and headache at the time of the switching over to the new driver.

Manufacturer Narrative

The 70 cc tah-t cannula piece will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Manufacturer Narrative

Visual external inspection of the left cannula(red side) showed the cannula had been spliced prior to replacement and had excessive wear near the cpc connector.The cannula was spliced 31 mm from the distal end prior to the cpc connector.The cannula appears to be discolored from a clear appearance to a dark gray appearance before the cpc barb.It was noticed that there was a large opening on the cannula 12 mm from the end of the cannula at the connector.The opening appears to span approximately 33 mm (95%) of the circumference and is 1 mm thick.After review from macro images, cannula does not appear to exhibit micro tears at the cpc barb connection.Visual internal inspection found no abnormalities or damage in the interior of the cannula.Functional and observational testing are not applicable to cannulae.Additional testing was performed to ensure the cpc connector did not require an excessive amount of force to be disconnected, which could lead to cannula damage.This test indicated that only standard force was required to disconnect the cpc connector and there were no indications of other performance issues of the connector, including o-rings appearing to be in good condition.Failure investigation for this complaint confirmed the reported issue via visual inspection; replicating the complaint is not necessary or applicable.The root cause of the customer reported cannula tear is primarily attributed to increased stress on the cannulae when the patient is supported by the portable driver and outside the hospital setting ; i.E., increased patient mobility.A second factor is material stability where pvc is negatively impacted by aging which impacts flexibility and elasticity of the material.Capa-2023-0001, cannula material degradation with long-term use, at investigation, was initiated to investigate and identify corrective action for this failure mode.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.(if new or additional information is received in the future, syncardia will file a follow-up mdr.) (b)(4).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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 15652848
• MDR Text Key: 302405880
• Report Number: 3003761017-2022-00114
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 500101
• Device Lot Number: XXXXXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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: 22 YR
• Patient Sex: Male