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

Model Number 3000TFX

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).The device was not returned to edwards for evaluation.Attempts to retrieve additional information and device is in process.If additional information is received a supplemental mdr will be submitted.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.Although bioprosthetic valves have been proven to have excellent long term durability, failure does occur in a small number of valves.Replacement of a bioprosthetic valve over time is more likely due to structural valve deterioration (svd) which occurs as a result of stenosis (from calcification or host tissue overgrowth), dehiscence, fibrosis or non-calcific degeneration and/or endocarditis.The cause of the event cannot be determined; however, patient factors may have contributed to the event.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

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.In this case, edwards implant patient registry received information a 23mm aortic valve was explanted after an implant duration of nine (9) months due to unknown reasons.A the explanted device was replaced with a 21mm aortic valve.Patient post-operative status noted as in recovery.

Manufacturer Narrative

H10: additional manufacturer narrative.Updated h6 per new information received.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10316940
• MDR Text Key: 200239060
• Report Number: 2015691-2020-12658
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S022
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2022
• Device Model Number: 3000TFX
• 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; Life Threatening; Required Intervention
• Patient Age: 73 YR