MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PR9

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problems Hematoma (1884); Perforation (2001)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

Hematomas may occur in the coronary sinus, these typically occur from over inflation of the balloon in relationship to the size of the vessel.Most will not require any intervention, but it may require a change in operative strategy relying solely on antegrade cardioplegia.In this case, the root cause of this event cannot be conclusively determined.However, the event was likely due to procedural related factors.It was reported that some resistance was felt upon advancement of the device and there was a coronary sinus perforation.There was a change in operative strategy and it was revealed that it was not a true perforation, but it was a coronary sinus injury that resulted in hematoma.The patient did not have friable tissue nor abnormal anatomy.Per the instructions for use (ifu), "if resistance is met, stop and re-evaluate proplege device position.The proplege device should not be advanced if resistance is felt, as doing so would cause the proplege device to bend or buckle.Aggressive advancement in an attempt to engage the ostium may result in perforation or other injury." the subject device will not be returned for evaluation due to customer refusal.The device history record (dhr) could not be reviewed, as the device serial number was not provided.There was no allegation or evidence of a device malfunction.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 during placement of a retrograde cardioplegia device, a perforation of the coronary sinus occurred.While placing the sinus catheter, a wire was used and the vessel looked normal without intrusion.Upon advancement some resistance was felt and venography was used to observe extravasation in the vessel which indicated a perforation of the coronary sinus.It was noted that upon initial placement of the device, the eustachian ridge and the middle cardiac branch came off right at the ostia.A surgeon was called and the case was converted to an open procedure.No effusion was noted on echo.The pericardium was opened and there was no blood in the pericardial fluid.Thus, there was no true perforation of the coronary sinus.The contrast just eviscerated into the fatty tissue and not into the pericardium.There was no blood loss due to the catheter.The patient did not have friable tissue nor abnormal anatomy.There was no allegation of malfunction against the device.The patient was reported to be stable and sitting up pod #1.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7710405
• MDR Text Key: 114709758
• Report Number: 3008500478-2018-00077
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PR9
• Device Catalogue Number: PR9
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 09/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR