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

Model Number 3300TFX19MM

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Insufficient Information (3190)

Patient Problems Death (1802); Ischemia (1942); Perforation (2001); Ventricular Tachycardia (2132); Aortic Dissection (2491)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

Aortic tears, or a tear of the aortic wall, may occur as a complication of cardiac surgery involving a diseased aortic root.Aortic tears are life threatening conditions that require urgent intervention.In this case, it was reported that the valve was unable to be seated and started to tear some of the back wall of the aorta requiring a root replacement.The device was not returned for evaluation as it was reported to have been discarded.Based on the available information, the root cause of the event remains indeterminable.However, it is likely that patient and procedural factors contributed to the event.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.In addition, the event does not allege a labeling issue or device related infection; therefore no dhr is required.

Event Description

It was reported that a 19mm 3300tfx was explanted at implant due to inability to pass through the sinotubular junction causing an aortic tear.Per obtained medical records, the aorta was opened in a transverse position higher than where we would normally open because of the proximal shelf of calcium.The aorta was fairly small.The trileaflet aortic valve was excised and sized to a 19 mm valve.Once all the valve sutures were placed circumferentially, these were passed through the sewing ring of the valve and once again, he attempted to seat the valve, but was unable to get the valve seated down on the annulus and actually started to tear some of the back wall of the aorta.The aorta was quite thin and friable in this area, so this was abandoned.As mentioned, they were able to get the sizer in, but just could not get the valve through.At this point, the surgeon decided to proceed with a root replacement with a 19 mm non-edwards valve.The patient had several episodes of v-tach and was unable to come off bypass.The surgeon decided to graft the lad in case there was some ischemia to the left ventricle.A balloon pump was also implanted and the patient came off bypass.The patient was not as hemodynamically stable this last time.The patient was requiring high dose pressors, high dose epinephrine and was being given epinephrine boluses and we ultimately could not support the blood pressure.Her left ventricle on the tee appeared to be moving, but function was not normal and she was on high doses of inotropic agents.The patient then expired in the operating room.

Manufacturer Narrative

Reference capa-20-00141.

• 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: 8117360
• MDR Text Key: 129055175
• Report Number: 2015691-2018-04942
• 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
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• Device Model Number: 3300TFX19MM
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR