MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART VALVE

Model Number 3300TFX

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Regurgitation (1716); Atrial Fibrillation (1729); Cardiac Arrest (1762); Occlusion (1984); Cardiogenic Shock (2262); Collapse (2416)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

Udi (b)(4).The device was not returned to edwards for evaluation.Partial or total occlusion or obstruction of the coronary ostia is a recognized complication of an aortic valve replacement and, less frequently, from mitral valve replacement.It is typically the result of a technical error during valve implant and not related to a product malfunction.However, partial or total occlusion of the ostia, if unrecognized, can result in angina, myocardial infarction, acute peri-operative right, left or bi-ventricular dysfunction and/or death.In this case, the patient experienced cardiac arrest and collapse due to the left main coronary artery occlusion and the valve was replaced with a smaller size valve.A definitive root cause cannot be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a 23mm valve was explanted at implant due to cardiac arrest and collapse due to left main coronary artery occlusion.A 21mm valve was implanted in replacement.The patient was transferred to the pacu in stable condition.The patient was discharged on pod #5.The patient presented with severe aortic regurgitation and underwent an aortic valve replacement with a 23mm valve.After protamine administration and decannulation was completed without difficulties, the patient had cardiac collapse and arrest requiring reinstitution of cardiac bypass.The echo suggested that there was poor flow down the left main artery.The patient was re-heparinized and aorta was cross clamped.The aorta was opened and the valve was inspected.It was unclear if the left main was obstructed but to be sure the valve was removed and downsized to a 21mm valve.At completion of weaning from bypass, the patient had excellent hemodynamics.The patient was transferred to the pacu in stable condition.The patient had one episode of atrial fibrillation with rapid ventricular rate on pod #2.The patient was discharged on pod #5.The implantation data card indicated that the device explant was not due to deficiency of the original device.

Manufacturer Narrative

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

Manufacturer Narrative

H10.Additional manufacturer narrative: updated sections h4 and h6.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10192325
• MDR Text Key: 199088129
• Report Number: 2015691-2020-12267
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2023
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR