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

Model Number 7000TFX

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 03/02/2020

Event Type  Injury  

Event Description

Edwards lifesciences maintains an implant patient registry (ipr).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.It was reported via the implant patient registry that a valve model 7000tfx31 implanted in the mitral position was repaired with pld occluder after an unknown implant duration due to paravalvular leak (pvl).Later on, the valve was explanted after an implant duration of eleven (11) years and one (1) month due to severe paravalvular, deep eccentric jet, peak gradient/mean gradient 12/32 mmhg and mild valvular insufficiency.A valve model 7300tfx29 was successfully implanted in replacement.Peak gradient/mean gradient post procedure 8/4 mmhg.No pvl.The patient spent a short time in intensive care according to standard protocol and was discharged.

Manufacturer Narrative

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 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 (ipr).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.It was reported via the implant patient registry that this valve model 7000tfx31 implanted in the mitral position was repaired with pld occluder after eight (8) years and seven (7) months of implant duration due to perivalvular leak (pvl).Later on, the valve was explanted after an implant duration of eleven (11) years and one (1) month due to severe paravalvular, deep eccentric jet, peak gradient/mean gradient 12/32 mmhg and mild valvular insufficiency.The patient presented with dyspnea nyha class iii and fatigue.A valve model 7300tfx29 was implanted in replacement.The patient spent a short time in intensive care according to standard protocol and was in good general condition and was discharged.

Manufacturer Narrative

Added information to section b5 (describe event or problem), d4 (expiration date) and h4 (device manufacturer date) updated section b4 (date of this report), g3 (date received by manufacturer), h6 (component code, health effect - clinical code, device code(s), type of investigation, investigation findings and investigation conclusions).H10: additional manufacturer narrative: the device was not returned for evaluation as it was discarded.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL 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 ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16127170
• MDR Text Key: 306984284
• Report Number: 2015691-2023-10048
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

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: 01/15/2012
• Device Model Number: 7000TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2008
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male