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

Device Problem Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2013

Event Type  Injury  

Event Description

Through review of medical article "the hemodynamic performance of the perceval sutureless aortic valve in a propensity-matched comparison to the carpentier-edwards perimount and perimount magna ease valves for aortic valve replacement", the following event was identified as pertaining to an edwards device: a patient with an unknown edwards perimount valve model implanted in the aortic position underwent a valve-related reintervention after an unknown implant duration due to significant paravalvular leakage of the valve.

Manufacturer Narrative

H10: additional manufacturer narrative: the date of the event is unknown; however, according to the article, the study period was from (b)(6) 2013 to (b)(6) 2017.Thus, the first day of the reported study period ((b)(6)2013) was used as the occurrence date.The device was not returned for evaluation.Attempts to retrieve the device and additional information were unsuccessful.Device current location remained unknown.Article citation: kueri s, berger t, puiu pc, alhamami y, diab n, czerny m, hochholzer w, siepe m.The hemodynamic performance of the perceval sutureless aortic valve in a propensity-matched comparison to the carpentier-edwards perimount and perimount magna ease valves for aortic valve replacement.Thorac cardiovasc surg.2023 oct;71(7):542-549.Doi: 10.1055/s-0042-1755207.Epub 2022 aug 20.Pmid: 35987191.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

Despite due diligent attempts to receive further information regarding this event, no additional information was received.The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.A definitive root cause cannot be conclusively determined; however, patient 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: 18814603
• MDR Text Key: 336620407
• Report Number: 2015691-2024-01487
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 03/25/2024
• 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): Hospitalization; Life Threatening; Required Intervention