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

Model Number 3300TFX

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

Implant date: implant date is unknown/not provided.Based on the device manufacturing date, the best estimate date would be july 2022.Attempts have been made to obtain the status of the explanted device for return.At this time, the device has not been provided.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 reported that a patient with a 3300tfx 25mm aortic valve was explanted after an implant duration of approximately 7 months due to aortic insufficiency.The patient was asymptomatic.The explanted valve was replaced with another 25mm 3300tfx valve, and the patient's outcome was stable at the end of the procedure.The pre-existing device implant date was not provided.Based on the device manufacturing date, the implant duration is approximately 7 months.

Manufacturer Narrative

Based on the additional information obtained, the device was received pending evaluation.A mfg.Date was inadvertently entered instead of unknown.

Event Description

It was reported that a patient with a 3300tfx 25mm aortic valve was explanted after an unknown implant duration due to aortic insufficiency.The patient was asymptomatic.The explanted valve was replaced with another 25mm 3300tfx valve, and the patient's outcome was stable at the end of the procedure.

Manufacturer Narrative

Product evaluation: customer report of aortic insufficiency was unable to be confirmed through visual observations.Corrective data: based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.

Event Description

It was reported that a patient with a 3300tfx 25mm aortic valve (sn (b)(6) was explanted at implant due to pvl.The explanted valve was replaced with another 25mm 3300tfx valve, and the patient's outcome was stable at the end of the procedure.Per medical records: the patient presented with cad, stable angina pectoris, mild doe, moderate as, mild ai, lvef 55%, and mild mr.The patient on (b)(6) 2023 underwent cabg x2 , a 25mm 3300tfx was implanted, it is noted this was challenging due to the calcification at the aortic root.The patient was weaned from cpb.A tee showed significant ai, due to pvl, cpb was resumed, it appeared the severe calcium along the non-coronary cusp may have been the cause of the ai encountered.The aortic annulus was further debrided a new 25mm 3300 tfx (sn (b)(6 was implanted.A tee demonstrated good biventricular function with trace ai.The patient was discharged on pod #7.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA 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: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16526937
• MDR Text Key: 311121809
• Report Number: 2015691-2023-11413
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00690103176155
• UDI-Public: (01)00690103176155(17)260508
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

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 Model Number: 3300TFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/15/2023; 05/30/2023
• Supplement Dates FDA Received: 04/11/2023; 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2022
• 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; Required Intervention; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Male