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

Model Number 7300TFX

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

Patient Problem Insufficient Information (4580)

Event Date 10/22/2012

Event Type  Injury  

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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was learned from implant patient registry that a 25mm 7300tfx mitral valve was explanted and replaced with another 25mm 7300tfx valve after an implant duration 9 months due to severe mitral regurgitation.Per medical records, the pre-existing 25mm 7300tfx valve was structurally intact.However, around the 7-9 quadrant, one could pass the tip of a right angle clamp, indicating the area of the leak while the remainder of the valve was nicely seated and healed.There was no granulation or evidence of active or healed endocarditis in the area.The valve was resected and the annulus was debrided.There was no evidence of endocarditis anywhere.The tissues did not seem horrible.Another 25mm 7300tfx valve was implanted in replacement without difficulty.Testing of the valve with a right angle clamp and a smaller clamp did not show any evidence of leak.A tv repair was also performed with an edwards annuloplasty ring within the same procedure.The patient came off bypass without difficulty or drips.Tee showed that the mitral valve had no perivalvular leak and functioned properly.The patient tolerated the procedure well and was returned to the recovery room in good condition.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.

Event Description

It was learned from implant patient registry that a 25mm 7300tfx mitral valve was explanted and replaced with another 25mm 7300tfx valve after an implant duration 9 months due to severe paravalvular leak (pvl).Per medical records, the pre-existing 25mm 7300tfx valve showed pvl.There was no granulation or evidence of active or healed endocarditis in the area.The valve was resected in its totality and all loose pledgets inserted previously were removed.The annulus was debrided.Another 25mm 7300tfx valve was implanted in replacement without difficulty.Testing of the valve did not show any evidence of leak.A tv repair was also performed with an edwards annuloplasty ring within the same procedure.The patient came off bypass without difficulty or drips.Tee showed that the mitral valve had no pvl and functioned properly.The patient tolerated the procedure well and was returned to the recovery room in good condition.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections d4 (expiration date), h4, h6 (type of investigation, investigation findings, investigation conclusions).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.The root cause of this event was determined to be due to procedural related factors, since, while resecting the valve, it was reported that 'all loose pledgets inserted previously were removed.' the subject device is not available for evaluation.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.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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15848443
• MDR Text Key: 304175277
• Report Number: 2015691-2022-09429
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S068
• 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
• Report Date: 01/06/2023

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: 10/23/2014
• Device Model Number: 7300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2010
• 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: 67 YR
• Patient Sex: Female