MAUDE Adverse Event Report: EDWARDS LIFESCIENCES 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA; CANNULA, CATHETER

Model Number OPTI20

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Ventilator Dependent (2395)

Event Date 01/19/2021

Event Type  Death  

Manufacturer Narrative

These cannulae are used to divert large volumes of blood between the patient circulation and the cardiopulmonary bypass machine during cardiac surgery and, on occasion, ecmo (off-label use).This malfunction/defect would likely require an exchange of the cannula resulting in a temporary interruption of bypass and possibly significant blood loss.The potential for serious injury before or during use is not remote.Per evaluation of received images, it was confirmed that the cannula body was partially torn on the wire reinforced section of the cannula body at the distal end with wire exposed.The cannula also appeared to have multiple kinks along the cannula body.Per the instructions for use (ifu), "do not use if device shows signs of damage (i.E., cuts, kinks, crushed areas), or if package is damaged or open." also, "this device is intended for short-term use only (< 6 hours)." in this case, the cannula had been used for 13 days, which was longer than six (6) hours stated in the ifu.A definitive root cause for the cannula damage could not be conclusively determined; however, it may have been caused by the movement of the patient.It appears that the device was intentionally used beyond its indicated duration of <6 hours.The device was not returned for evaluation due to infection.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that the cannula body of an opti20 was partially torn during use.The cannula had been used for circulatory support with ecmo for a patient with covid-19 and inserted into the right internal jugular vein.Reportedly, this cannula was selected considering the patient's extreme obesity in this case, although they usually use a different model of cannula to connect with ecmo.On the 13th day from cannula connection, the patient condition did not recover, and the patient was moved for tracheostomy surgery.The cannula body was partially (approximately 80%) torn and severe bleeding occurred.The cannula was not manipulated when it tore.The patient went into cardiac arrest and his heart was restarted by life-saving measure; however, the patient was still in a condition of hypoxia and high level of carbon dioxide in the blood was concurrently observed.The patient had been treated with using ventilator in the icu; however, seven (7) days after the event, the patient passed away in the morning.The doctor commented that it was difficult to expose the blood vessels and perform re-cannulation due to the patient's extreme obesity, so they were unable to put him back on ecmo.Detailed information such as the patient's condition or treatments performed in icu was unavailable.

• Brand Name: 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA
• Type of Device: CANNULA, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: amritha srinivasan ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492504062
• MDR Report Key: 11319024
• MDR Text Key: 231568200
• Report Number: 2015691-2021-01235
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OPTI20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 27 YR
• Patient Weight: 190