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

Model Number 3300TFX

Device Problems Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

H10: additional 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 via implant patient registry that a patient with a 25mm 3300tfx aortic valve was explanted after an implant duration of one month due to unknown reason.The replacement valve is a 23mm 3300tfx valve.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.

Manufacturer Narrative

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.Per technical summary 33069, rev a, 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 most likely cause is procedural factors, including the annular calcium that was left after the annulus was debrided and the right fistula that was probably due to the initial procedure.All pertinent information available to edwards lifesciences has been submitted.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b4, b5, b7, g3, g6, h2, h6 (component code, clinical code, device code, type of investigation).

Event Description

It was learned via implant patient registry that a patient with a 25mm 3300tfx aortic valve was explanted after an implant duration of one month due to pvl and aorto right atrial fistula.The replacement valve is a 23mm 3300tfx valve.Per medical record: the patient presented with increasing sob, diagnostic echo showed a large bioprosthetic valve pvl, tee confirmed the presence of an aorto right atrial fistula.The patient underwent a complete left atrial maze procedure and laa ligation.It is noted the 25mm 3300tfx aorta valve sutures were all intact.On examination, there was a decent sized portion of the aortic annulus in the area of the non-coronary cusp completely separated from the aortic wall with a fistula in that region, which it is noted could represent the source of the problem.The annulus appeared to have significant calcium in it even after being debrided.The fistula was repaired and the 25mm 3300tfx replaced with a 23mm 3300tfx aortic valve.The patient was transferred to cvu in stable condition.The patient overnight developed worsening cardiogenic shock related to rv failure and hypoxia.An echo showed rv failure, a preserved lv, a well-functioning aortic prosthetic valve, no significant pericardial effusion and no signs of tamponade.On pod # 1 the patient was placed on ecmo and hemodynamically stable with ecmo.The patient was transported to cvu in stable condition.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17140441
• MDR Text Key: 317296972
• Report Number: 2015691-2023-13907
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103176155
• UDI-Public: (01)00690103176155(17)240413
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2023

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: 04/13/2024
• Device Model Number: 3300TFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 06/15/2023; 08/04/2023
• Supplement Dates FDA Received: 07/13/2023; 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2020
• 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: 71 YR
• Patient Sex: Male