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

Model Number 3300TFX

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pseudoaneurysm (2605); Insufficient Information (4580)

Event Date 04/20/2023

Event Type  Injury  

Event Description

It was learned via implant patient registry that a 25mm aortic valve was explanted after an implant duration of 5 years, 1 months due to unknown reason.The explanted valve was replaced with a 25mm valve.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

H10: additional narratives: surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned for evaluation, as device request is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

H10: additional narratives: updated b5, b7, and h6 per new information received.

Event Description

It was learned via implant patient registry that a 25mm 3300tfx aortic valve was explanted after an implant duration of 5 years, 1 months due to severe valve dysfunction, dehiscence, elevated gradients, moderate regurgitation, and mild-to-moderate perivalvular leak.The patient presented with sob and lvot pseudoaneurysm.The explanted valve was replaced with a 25mm 11500a valve.Per medical records the 25mm replacement valve was sewn into a 28mm gel weave graft; an 8mm hemashield graft and a 6mm hemashield graft were sewn in an end-to-end fashion to the left man coronary artery and the right main coronary artery, respectively.The patient tolerated the procedure well and was taken to the sicu in stable condition.The patient was discharged on pod #11.

Manufacturer Narrative

The most likely cause is patient factors.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this 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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17121545
• MDR Text Key: 317112507
• Report Number: 2015691-2023-13671
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103176155
• UDI-Public: (01)00690103176155(17)211227
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2021
• Device Model Number: 3300TFX
• Device Catalogue Number: 3300TFX25MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 06/27/2023; 07/31/2023
• Supplement Dates FDA Received: 07/21/2023; 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Male