MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS; TISSUE, HEART-VALVE

Model Number 11000A

Device Problems Calcified (1077); Fluid/Blood Leak (1250); Difficult to Open or Close (2921)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Calcification is a well-recognized failure mode of bioprosthetic valves.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), and mechanical stress related to the valve's hemodynamic performance.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Although patient factors are believed to play a crucial role in the development in bioprosthetic tissue calcification, the underline mechanism is still not fully understood.The device was not returned for evaluation, as it remains implanted.Minimal information regarding this procedure was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful.The root cause of the event remains indeterminable.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported via clinical trial that a patient with a 25mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 7 years, 6 months due to calcification and motion restricted.

Event Description

It was reported via clinical trial that a patient with a 25mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 7 years, 6 months due to calcification, motion restricted, and mild regurgitation.The patient presented with doe.

Manufacturer Narrative

The root cause of this event cannot be conclusively determined.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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

The echo at the 9-year follow-up visit showed higher peak systolic gradient and higher mean systolic gradient.

Event Description

It was reported via clinical trial that a patient with a 11000a 25mm aortic valve underwent a valve-in-valve procedure after an implant duration of 7 years, 6 months due to calcification, severe stenosis, motion restricted, and mild regurgitation.The patient presented with doe.

Manufacturer Narrative

H10: additional narratives: updated b5 and h6 per new information received.

Manufacturer Narrative

Updated b5 and h6 per new information received.

Event Description

It was reported via commence clinical trial that a patient with a 11000a 25mm aortic valve underwent a valve-in-valve procedure after an implant duration of 7 years, 6 months due to calcification, severe stenosis, motion restricted, and mild regurgitation.The patient presented with nyha iii, doe, fatigue, lower extremity, and chest tightness.The tavr procedure was completed successfully using a 26mm sapien 3 ultra transcatheter valve was.

• Brand Name: EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS
• 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: gail warner ; one edwards way; mailstop 6.1 anton; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12465147
• MDR Text Key: 271306043
• Report Number: 2015691-2021-05162
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2014
• Device Model Number: 11000A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2013
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Male