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

Model Number 6900

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 01/01/1984

Event Type  Injury  

Event Description

Through review of medical article "durability of bovine pericardial mitral bioprosthesis based on heart valve collaboratory echocardiographic criteria", the following event was identified as pertaining to an edwards device: 3 patients with a carpentier edwards perimount implanted in mitral position underwent reoperation due to valve dehiscence after an unknown implant duration.

Manufacturer Narrative

H10: additional manufacturer narrative: this is one of five manufacturer reports being submitted for this article.Refer to medwatch number (b)(4) for events within the same article.The date of the event is unknown; however, according to the article, the study period was from 1984 to 2016.Thus, the first day of the reported study period ((b)(6) 1984) was used as the occurrence date.Article citation: kermen s, aupart a, bonal m, strella j, aupart m, espitalier f, morisseau m, bernard a, bourguignon t, durability of bovine pericardial mitral bioprosthesis based on heart valve collaboratory echocardiographic criteria, the journal of thoracic and cardiovascular surgery (2023), doi: https://doi.Org/10.1016/j.Jtcvs.2023.11.021.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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.

Manufacturer Narrative

Added information to section h6 ( device code), h6 (investigation findings) and h6 (investigations conclusions) corrected data h6 ( device code): "2907 - detachment of device or device component" code removed.H10: additional manufacturer narrative: the device was not returned to edwards for further investigation and no images or medical records were provided.Device dehiscence or suture torn out may occur early or late.When it occurs in the intraoperative period, it is typically a result of inadequate device implantation in combination with friable myocardial tissue.Valve dehiscence is not a malfunction related to a manufacturing deficiency of the device.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL MITRAL 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: 18518180
• MDR Text Key: 332929489
• Report Number: 2015691-2024-00422
• Device Sequence Number: 1
• Product Code: DYE
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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