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

Model Number 3300TFX

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Patient-Device Incompatibility (2682); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Insufficient Information (4580)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.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

Through implant patient registry it was learned a 21mm 3300tfx aortic valve was explanted after three (3) years, due to unknown reasons.The explanted device was replaced with a 23mm 11500a aortic valve.Explant was not due to deficiency in the original device.Patient post-operative status noted as in recovery.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

Through implant patient registry and medical records, it was learned a 21mm 3300tfx aortic valve was explanted after three (3) years, due to severe perivalvular (pvl) aortic insufficiency and severe aortic stenosis.The explanted device was replaced with a 23mm 11500a aortic valve.Explant was not due to deficiency in the original device.The patient was transferred to icu in stable condition.Per medical records, patient reported that her first post op echo in 2020 post implant of 21mm 3300tfx demonstrated leak of the valve but patient never saw the surgeon.Patient had extensive dental extractions and ended up getting bacteremia.Patient was treated with antibiotics for endocarditis but tee did not demonstrate vegetation.Patient presented with worsening fatigue over the last year.Intraoperative tee demonstrated severe pvl with normal functioning valve leaflets.There was pannus around the sewing ring, but no obvious defect causing pvl.The 21mm 3300tfx aortic valve was explanted and a 23mm 11500a aortic valve implanted.Patient tolerated the procedure well and was transferred to icu in stable condition.The patient was discharged home in good condition on pod# 6.

Event Description

Through implant patient registry and medical records, it was learned a 21mm 3300tfx aortic valve was explanted after three (3) years, due to severe perivalvular (pvl) aortic insufficiency, patient prosthetic mismatch and aortic stenosis.The explanted device was replaced with a 23mm 11500a aortic valve.Explant was not due to deficiency in the original device.The patient was transferred to icu in stable condition.Per medical records, patient reported that her first post op echo in 2020 post implant of 21mm 3300tfx demonstrated leak of the valve but patient never saw the surgeon.Patient had extensive dental extractions and ended up getting bacteremia.Patient was treated with antibiotics for endocarditis but tee did not demonstrate vegetation.Patient presented with worsening fatigue over the last year.A subsequent cardiac cath demonstrated moderate to severe aortic insufficiency, moderate aortic stenosis( possible ppm) with normal coronaries.An echo prior to surgery demonstrated severe aortic paravalvular regurgitation, early peaking and mean avg of 23mmhg.At time of surgery the intraoperative tee demonstrated severe pvl with normal functioning valve leaflets.It is noted in the medical record there is a valve mismatch from previous surgery.There was pannus around the sewing ring, but no obvious defect causing pvl.The 21mm 3300tfx aortic valve was explanted and a 23mm 11500a aortic valve implanted.Patient tolerated the procedure well and was transferred to icu in stable condition.The patient was discharged home in good condition on pod# 6.

Manufacturer Narrative

Corrected b5, b7.H6.Added to h6.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed, including the history of endocarditis.The cause of the patient prosthesis mismatch was most likely due to operational context from time of implant.

Manufacturer Narrative

The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed, including the history of endocarditis.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18185542
• MDR Text Key: 328740145
• Report Number: 2015691-2023-17654
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103176131
• UDI-Public: (01)00690103176131(17)270323
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057/S042
• 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,Followup
• Report Date: 01/16/2024

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: 03/27/2023
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/05/2023; 01/16/2024; 01/16/2024
• Supplement Dates FDA Received: 12/28/2023; 01/16/2024; 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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
• Patient Age: 63 YR
• Patient Sex: Female