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

Model Number 11500A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Pulmonary Regurgitation (2023)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

Di (b)(4).The device was not returned to edwards for evaluation.The device history record (dhr) 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.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration.However, advances in valve design and bioprosthetic material have been made with the intention of reducing leaks by providing more efficient hemodynamics and longer tissue durability.A definitive root cause could not be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a 19mm valve implanted in pulmonary position for ten months was explanted due to severe pulmonary valve regurgitation.A 21mm valve was implanted in replacement.The patient transferred to the pediatric icu in stable condition.The patient was discharged on pod #7.The implantation data card indicated that the device explant was not due to deficiency of the original device.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: amritha srinivasan ; 1 edwards way; irvine, CA 92614 ; 9492504062
• MDR Report Key: 10519403
• MDR Text Key: 206497121
• Report Number: 2015691-2020-13503
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2020
• Date Device Manufactured: 09/12/2018
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 1 YR
• Patient Weight: 13