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

Model Number 7300TFX27

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Mitral Valve Stenosis (1965); No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

Post-operatively, the body undergoes various phases of the tissue response continuum resulting in the fibrous encapsulation of the implanted annuloplasty ring.Local and systemic factors of the patient may play a role in the wound healing and inflammatory responses to biomaterials and implants.The subject device was not returned for evaluation as it remains implanted.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.In this case, a definitive root cause for early pannus could not be conclusively determined.However, there are no indications of a manufacturing defect.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received notification that this (b)(6) y o patient with a valve model 7300tfx27 implanted in the mitral position underwent surgery for a valve-in-valve replacement after an implant duration of 7 years and 9 months due to stenosis (trans gradient 14-19mmhg observed on echo) and significant pannus formation.A 29mm sapien3 valve was successfully implanted within the surgical edwards valve using the transfemoral transseptal approach.The patient was noted as to be recovering in hospital with anticipated next day discharge.The op report is not available.As reported, during initial surgery in 2012 the patient also received a valve model 3300tfx25mm in the aortic position which was observed to be functioning well.

Manufacturer Narrative

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

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10393509
• MDR Text Key: 202944239
• Report Number: 2015691-2020-13030
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S068
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2015
• Device Model Number: 7300TFX27
• 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: 81 YR