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

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Aortic Regurgitation (1716); Congestive Heart Failure (1783); Endocarditis (1834); Myocardial Infarction (1969); Sepsis (2067); No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

Udi#: (b)(4).The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information are in process.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.Based on the information received the cause of the event cannot be determined.If additional information is received a supplemental mdr will be submitted.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

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.It was reported through implant patient registry, a patient originally implanted with a 23mm aortic valve for 1 months 7 days, underwent an explant procedure for unknown reasons.The patient received a replacement 23mm aortic valve.The current patient status is unknown.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Event Description

It was learned through the receipt of medical records, the patient originally implanted with a 23mm aortic valve for 1 months 7 days, underwent an explant procedure due to acute aortic valve endocarditis -enterobacter cloacae, large vegetations, sepsis and aortic insufficiency.The patient presented with congestive heart failure, myocardial infarction and septic emboli.The patient received a replacement 23mm aortic valve.The patient was transferred to icu in guarded condition.The patient was discharged pod #8.

Manufacturer Narrative

H10: updated b5, b7, patient codes, device codes, method codes, result codes, conclusion codes; additional manufacturer narrative: the clinical observation was confirmed through receipt of medical records.Prosthetic endocarditis, with or without vegetation, of valves and annuloplasty rings is a serious complication of cardiac valve replacement and valve repair surgeries despite improvements in prostheses types, surgical techniques, and infection control measures.This infection is generally categorized into early (onset usually less than 60 days postoperative) and late (onset greater than 60 days post-implantation).Prosthetic endocarditis occurring within 60 days of valve or ring implantation generally reflects contamination arising in the perioperative period.There are many opportunities for organisms to seed a prosthesis peri-operatively, most of which probably occurs intraoperatively.Besides the patient's own skin and access lines, several other important modes of contamination have been recognized including air in the operating room, the coronary suction devices used during surgery and the heart-lung bypass machine, faulty technique during cardiac output measurements, and the prosthesis itself.In early cases of prosthetic endocarditis, subsequent infections are almost universally related to contamination at the time of surgery.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.The root cause of the event remains indeterminable, however, patient and/or procedure related factors may have contributed.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9924997
• MDR Text Key: 186750101
• Report Number: 2015691-2020-11326
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: 11500A
• Device Lot Number: R-19A0444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR