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

Model Number 2700

Device Problems Degraded (1153); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Aortic Valve Stenosis (1717); Stenosis (2263)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.Pannus can have both beneficial and harmful effects depending on the amount of growth.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.Depending on the severity of the pannus, it may or may not require intervention.The device was not returned for evaluation, as it was discarded.The root cause of this event cannot be conclusively determined.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported via patient registry that a 21mm aortic valve was explanted and replaced with a 25mm valve after an implant duration of 6 years, 5 months due to sizing issue, severe stenosis, patient-prothesis mismatch, pannus formation, and mildly thickened leaflet.Patient was discharged in stable condition on pod #5.As reported, no device malfunction was alleged.Per medical records patient underwent avr and annular enlargement.The previous valve stents were actually scarred to the aortic sinus wall.There was excess pannus scar formation around the valve sewing ring as well as around all of the large pledgets that were in the lv outflow tract.Sutures and scar came very close to the orifice of the left main, which was actually a combined right and left main coronary.The actual pericardial leaflets of the previous bioprosthesis had minimal visible degenerative changes.The replacement valve had good function with no pvl.All leaflets moved well.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.

Manufacturer Narrative

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

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9808159
• MDR Text Key: 190836336
• Report Number: 2015691-2020-10869
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2016
• Device Model Number: 2700
• Device Lot Number: R-12J3237
• 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: 78 YR