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

Model Number PR9

Device Problem Positioning Problem (3009)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.Vascular perforations may occur with the use of the device.A perforation is typically the result of excessive force combined with challenging anatomy and not a malfunction of the device.In this case, there was placement difficulty due to the native aneurysm affecting the position of the heart, and imaging difficulties.The cause of the event cannot be determined; however, procedural and and patient factors may have contributed to the event.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported that the middle cardiac vein was inadvertently cannulated during an ascending aortic aneurysm repair while a pr9 was about to be placed into the coronary sinus.There was placement difficulty due to the native aneurysm affecting the position of the heart, and imaging difficulties.The middle cardiac vein was disrupted and the systemic pressure began to slump.A pericardial effusion was discovered on tee and patient was suffering from cardiac tamponade.The procedure was scheduled as a hemi-sternotomy, and converted to a full sternotomy.The pericardium was opened and drained.The back of the heart was interrogated, and the injury was discovered and repaired.Patient's hemodynamics returned to normal and the procedure progressed normally.The anesthesiologist had a significant amount of experience with the pr9.

Manufacturer Narrative

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

• Brand Name: PROPLEGE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8975855
• MDR Text Key: 157042194
• Report Number: 3008500478-2019-00156
• 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: 08/16/2019

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: 08/16/2019
• Initial Date FDA Received: 09/09/2019
• 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): Required Intervention