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

Model Number PR9

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Cardiac Output (2501)

Event Date 04/20/2015

Event Type  Injury  

Event Description

Edwards received information that the patient¿s left ventricle (lv) failed after a mitral valve surgery that lasted for twenty hours.The case was a very complicated robotic mitral valve repair surgery that transitioned from-to-to a repair-repair-replace surgery.After the initial mitral valve repair with a non-edwards annuloplasty ring, for unknown reasons, the surgeon performed another repair.After the second repair with a non-edwards ring, the ring dehisced prompting the surgeon to perform mitral valve replacement with a non-edwards valve.With these multiple procedures, the bypass and crossclamp times were very long for this surgery.After the multiple mitral procedures, when attempting to wean off bypass, the patient was noted to have left ventricular failure.The patient was subsequently placed on extracorporeal membrane oxygenation (ecmo) and a left ventricular assist device (lvad).During the case, an intra-aortic occlusion device was used to administer the first dose of cardioplegia via the antegrade route.After the first dose of cardioplegia, the case transitioned to retrograde cardioplegia via the peripheral retrograde cardioplegia catheter.At no time during the case was there any sign or indication that retrograde cardioplegia was not being effectively delivered so the catheter was not repositioned.The flows and pressures monitored via the retrograde cardioplegia catheter were acceptable and there was no spontaneous return of electrical activity observed during the case.The first dose of cardioplegia (antegrade) was 800cc.The subsequent dose of cardioplegia (retrograde) was 400cc.The cardioplegia was redosed every 90 minutes during the case and was administered via the retrograde route.No signs of cardiac activity between doses were noticed.The coronary sinus pressures, cardioplegia flows and line pressures were in line with expectations when administering the cardioplegia solution.There was no reason for concern during the case.An edwards¿ representative was in the case.At the time the edwards representative left, there was nothing observed to indicate there was a problem with the edwards devices.After device placement, the anesthesiologist managing the retrograde cardioplegia catheter used echo to verify position.Repeated echo imaging well after the initial retrograde cardioplegia catheter placement was performed to confirm the catheter placement while the first dose of retrograde cardioplegia was being administered.The physician confirmed flow to the coronary vessels.The correct position and functioning of the retrograde cardioplegia catheter during the first retrograde dose was with a high level of certainty with this additional assessment for placement confirmation.Initially, during retrograde cardioplegia catheter placement, it was known the tip of the catheter was placed shallow but by the time the patient went on bypass the placement was confirmed to be in good position.The anesthesiologist and the perfusionist both felt the retrograde cardioplegia catheter worked as intended and the catheter was not the root cause of this patient¿s ventricular failure.The surgeon wondered if the patient had adequate cardiac protection with the retrograde cardioplegia administered via the retrograde cardioplegia catheter.There was no allegation of malfunction of the retrograde cardioplegia catheter as there were no indications during the case the device was not functioning as intended.The patient was a 27 year old female with a history of iv drug abuse.Within the year preceding this mitral valve replacement, she was diagnosed with cardiomyopathy.Additional past medical history and baseline cardiac function was not reported.Post-operatively the patient was on ecmo and lvad support waiting for evaluation for a heart transplant.

Manufacturer Narrative

The device was not returned to edwards for analysis as the device was discarded by the hospital staff.There was no allegation of product malfunction reported.Based on the information received, the root cause of this adverse patient outcome does not appear to be device related.The left ventricular failure was likely related to a combination of one or more of the following: extensive operative and cardiopulmonary bypass time, primary reliance on retrograde cardioplegia after the initial antegrade dose for this extended case and the patient's underlying cardiomyopathy.The instructions for use (ifu) and edwards' elearning module were reviewed.No inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Edwards will continue to review and monitor all events and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Additional manufacturer narrative: manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.

• Brand Name: PROPLEGE PERIPHERAL RETROGARDE CARDIOPLEGIA DEVICE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 8402 0
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4789113
• MDR Text Key: 16173389
• Report Number: 3008500478-2015-00032
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2015

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 Expiration Date: 03/01/2016
• Device Model Number: PR9
• Device Lot Number: 60044996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2014
• 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 Outcome(s): Disability
• Patient Age: 27 YR
• Patient Weight: 65