MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; TISSUE, HEART-VALVE

Model Number 11500A

Device Problems Calcified (1077); Gradient Increase (1270); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Additional narratives: 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 returned and product evaluation is ongoing.If new information becomes available, a supplemental report will be submitted.

Event Description

It was learned from implant patient registry that a 23mm aortic valve was explanted and replaced with another 23mm valve after an implant duration of 1 years, 6 months due to calcification, motion restricted, and severe stenosis.Per medical records the patient presented with severe acute on chronic combined systolic and diastolic chf.The patient underwent redo-avr and cabg x 2.Tee demonstrated a well-seated and well-functioning valve.The patient was discharged on pod #11.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.

Event Description

It was learned from implant patient registry that a 23mm aortic valve was explanted and replaced with another 23mm valve after an implant duration of 1 years, 6 months due to calcification, motion restricted, and severe stenosis.Per medical records the patient presented with myocardial infarction, severe acute on chronic combined systolic and diastolic chf.The patient underwent redo-avr and cabg x 2.Tee demonstrated a well-seated and well-functioning valve.The patient was discharged to rehab in an improved condition on pod #11.

Manufacturer Narrative

H10: additional narratives.Updated b5 per new information received.

Manufacturer Narrative

Product evaluation: heavy calcification, minimal to moderate pannus and torn leaflets were also identified.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.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• 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: 12489144
• MDR Text Key: 272146136
• Report Number: 2015691-2021-05227
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2019
• 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 Age: 49 YR
• Patient Sex: Male