MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300AB

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020)

Event Date 07/14/2022

Event Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation.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

Edwards received a notification that an elite valve model 8300ab23 was explanted due to paravalvular leak (pvl).As reported, the event occurred 30 minutes after the implantation, when the surgeon was finishing tying the last struts of the chest.Reportedly, first postoperative echo showed good result, however the second one after pulmonary edema and pressure drop showed paravalvular leak.Per medical opinion the edwards valve was chosen correctly and was working as intended at first, patient's frail tissue and expansion of the native annulus likely contributed to the pvl.A 25 mm non-edwards valve was implanted in replacement.Reportedly the patient died due to postoperative bleeding discovered several hours after the reoperation with the non-edwards valve.

Event Description

Edwards received a notification that this elite valve model 8300ab23 was explanted due to paravalvular leak (pvl).As reported, the event occurred 30 minutes after the implantation, when the surgeon was finishing tying the last struts of the chest.Reportedly, first postoperative echo showed good result, however the second one after pulmonary edema and pressure drop showed paravalvular leak.Per medical opinion the edwards valve was chosen correctly and was working as intended at first, patient's frail tissue and expansion of the native annulus likely contributed to the pvl.A 25 mm non-edwards valve was implanted in replacement.The patient had postoperative bleeding after the reoperation with the non-edwards valve.As reported, the bleeding was probably due to the reoperation.Unfortunately, the patient died due to heart failure on postoperative day 3.

Manufacturer Narrative

The device history record (dhr) review showed that this device passed all manufacturing inspections prior to release.No non conformances were identified that could be related with the reported event.Paravalvular leak (pvl) refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.It may occur as a result of a lack of appropriate sealing of the valve at the annulus or improper seating.The most common reason for pvl is inadequate debridement of a calcified annulus and is not a result of device malfunction.A definitive root cause cannot be conclusively determined; however, procedural factors likely caused or contributed.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15189601
• MDR Text Key: 297498390
• Report Number: 2015691-2022-07221
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG