MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART-VALVE

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

H11: additional manufacturer narrative: since it was not possible to distinguish between intuity valves and intuity elite valves in the rdavr group, ni was used in d1, d4 and g4 as model number is unknown.The date of the event is unknown; however, according to the article, the study period was from january 2012 to january 2017.Thus, the first day of the reported study period (1 of january 2012) was used in fiel b3 as date of event.Article citation: taghiyev zt, bechtel m, schlomicher m, useini d, taghi hn, moustafine v, strauch jt.Early term results of rapid deployment aortic valve replacement versus standard bioprosthesis implantation combined with coronary artery bypass grafting.Thorac cardiovasc surg.2023 oct;71(7):519-527.The subject device is not available for evaluation as it remains implanted in the patient.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.

Event Description

Medical article "early-term results of rapid-deployment aortic valve replacement versus standard bioprosthesis implantation combined with coronary artery bypass grafting" , the following event was identified as pertaining to edwards devices: eight (8) patients with unknow edwards aortic valves implanted in the aortic position presented severe patient prosthesis mismatch (ppm) after an unknown implant duration.Four (4) patients belonged to the rapid-deployment edwards intuity valve system (rdavr) group and the other four (4) patients belonged to the conventional sutured valves (csavr) group.

Manufacturer Narrative

H11: additional manufacturer narrative: the serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.Patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.Ifu review unable to be performed as the model is unknown.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• Brand Name: NI
• 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: 19048958
• MDR Text Key: 339431225
• Report Number: 2015691-2024-02603
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other