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

Model Number 8300AB21

Device Problems Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

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 the patient registry that a 21mm 8300ab intuity valve in the aortic position was explanted after an implant duration of one (1) day due to valve distortion which developed moderate-severe pvl.The patient presented with shortness of breath.The explanted valve was replaced with a 21mm 11500a valve.The patient was sent to the ccu in stable condition post procedure.

Event Description

It was learned via the patient registry that a 21mm 8300ab intuity valve in the aortic position was explanted after an implant duration of one (1) day due to moderate-severe pvl.The explanted valve was replaced with a 21mm 11500a valve.The patient was sent to the ccu in stable condition post procedure.Per medical records, the patient presented with stemi and sob.The patient underwent avr with 21mm 8300 valve, cabg, and closure of right femoral artery pseudoaneurysm.The 21mm 8300ab intuity aortic valve was implanted.The valve was properly seated and there was excellent apposition along the right and left coronary cusps.The tee showed a very small pvl along the non-coronary cusp with good lv and rv function.After giving a small amount of protamine the patient became hypotensive and had biventricular failure.At higher cpb pressures the function was completely normal.Despite high dose pressors they were unable to wean the patient from cpb.The surgeon noted concern that there was ongoing ischemia or coronary vasospasm.The patient was left on central ecmo and then transported to the icu in critical condition.On pod# 1, the patient was brought to the cath lab to evaluate for residual ischemia.Aortogram showed a new moderate to severe pvl and a distorted valve.There was a concern that the bioprosthetic valve had gotten displaced by the pressure of the antegrade flow from the ecmo circuit.The patient was brought back to the or and the 21mm 8300ab valve was explanted and replaced with a 21mm 11500a valve.The valve was properly seated.Due to pulmonary htn with poor lv filling, the patient was placed back on ecmo.The patient was sent to the ccu in stable condition.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections d4 (expiration date), h4, h6 (type of investigation, investigation findings) 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 explanted device is not available for evaluation.The root cause of this event was determined to be most likely due to procedural related factors, including valve distortion and displacement from the flow of the ecmo circuit.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.H11: corrected data: corrected sections b5, h6 (component code, health effect-clinical code, investigation conclusions).

Event Description

It was learned via the patient registry that a 21mm 8300ab intuity valve in the aortic position was explanted after an implant duration of one (1) day due to moderate-severe paravalvular leak (pvl).The explanted valve was replaced with a 21mm 11500a valve.The patient was sent to the ccu in stable condition post procedure.Per medical records, the patient presented initially with stemi and sob.The patient underwent avr with 21mm 8300 valve, cabg x3, and closure of right femoral artery pseudoaneurysm.The 21mm 8300ab intuity aortic valve was implanted.The valve was properly seated and there was excellent apposition along the right and left coronary cusps.The tee showed a very small pvl along the non-coronary cusp with good lv and rv function.After giving a small amount of protamine the patient became hypotensive and had biventricular failure.Despite high dose pressors they were unable to wean the patient from cpb.The patient was left on central ecmo and then transported to the icu in critical condition.On pod# 1, the patient was brought to the cath lab due to concern for ischemia and all coronary grafts were patent.Aortogram showed a new moderate to severe pvl and a distorted valve due to the antegrade flow from the ecmo support.The patient was brought back to the or and the 21mm 8300ab valve was explanted and replaced with a 21mm 11500a valve.The valve was properly seated.Due to pulmonary htn with poor lv filling, the patient was placed back on ecmo.The patient was sent to the ccu in stable condition.

Manufacturer Narrative

H10: additional manufacturer narrative: updated: b4, g3, g6, h2, h6.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 valve distortion and displacement from the flow of the ecmo circuit.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16305584
• MDR Text Key: 308869865
• Report Number: 2015691-2023-10607
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194487
• UDI-Public: (01)00690103194487(17)250726
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8300AB21
• Device Catalogue Number: 8300AB21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2023
• Date Device Manufactured: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female