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

Model Number 8300AB

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 01/05/2022

Event Type  Injury  

Manufacturer Narrative

Additional narratives: stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd), a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors, and is not usually an indication of a device malfunction.The device was not returned for evaluation, as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

It was reported that a patient with a 23mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 4 years, 2 months due to stenosis.

Manufacturer Narrative

H10: additional manufacturer narrative: updated b3 and b5.

Event Description

It was reported that a patient with a 8300ab 23mm aortic valve was disabled via a valve-in-valve procedure after an implant duration of 4 years, 2 months due to degeneration, severe stenosis, and mild regurgitation.The patient presented with nyha class 3.A 9750tfx 23mm was implanted successfully.

Event Description

It was reported that a patient with a 23mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 4 years, 2 months due to degeneration, severe stenosis, and mild regurgitation.The patient presented with nyha class 3.Per medical records, the physician suspects the esrd status has contributed to early avr degeneration.

Manufacturer Narrative

H10: additional narratives tissue degeneration related structural deterioration either calcific or non-calcific are common chronic failure modes for this type of bioprosthetic heart valves.The operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.

Manufacturer Narrative

Manufacturer narrative: updated sections: d4 expiration date, h4, h6 type of investigation, investigation findings, and investigation conclusions.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.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.Corrected data: section h6 health effect - impact code.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, 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: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13012540
• MDR Text Key: 286499573
• Report Number: 2015691-2021-06850
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194494
• UDI-Public: (01)00690103194494(17)210306
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/03/2022

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: 03/06/2021
• Device Model Number: 8300AB
• Device Catalogue Number: 8300AB23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 01/05/2022; 01/31/2022
• Supplement Dates FDA Received: 01/07/2022; 01/28/2022; 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• 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; Hospitalization; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male