MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART VALVE

Model Number	6900P
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Endocarditis (1834); Insufficient Information (4580)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available for evaluation, not available for return.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
Through the implant patient registry, it was reported that a patient with a 33mm 6900p mitral valve implanted in the tricuspid position for 2 years, 9 months was explanted due to unknown reasons.The device was replaced with a 31mm 7300tfx valve.Patient in recovery.No other details provided.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.
Additional Manufacturer Narrative
Additional manufacturer narrative: updated sections: b5, b7, and h6.Prosthetic endocarditis is a serious complication of valve replacement and repair surgeries despite improvements in prostheses types, surgical techniques, and infection control measures.This infection is generally categorized into early (onset at 60 days or less postimplant) and late (onset greater than 60 days post-implant).Early-onset generally reflects contamination arising in the perioperative period; if there were ever non-conformances in the sterility or packaging processes, they would most likely manifest at this time.Late-onset occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the body and is not related to the sterilization or packaging process.In this case the onset was greater than 60 days post-implant.It has been determined that the root cause of this event was most due to patient related factors and is not related to any manufacturing or sterilization issues with the valve.Corrected data: based on the new information received, this event is no longer considered reportable.
Event or Problem Description
Through the implant patient registry, it was reported that a patient with a 33mm 6900p mitral valve implanted in the tricuspid position for 2 years, 9 months was explanted due to endocarditis.The device was replaced with a 31mm 7300tfx valve.Patient expired on pod#4.Per medical records, patient also underwent repair ascending aortic pseudoaneurysm with hemashield patch, removal of wireless pacemaker.The prosthetic valve was removed and replaced with a 31mm 7300tfx valve.Post operative echo confirmed good valve function.The patient was transferred to the postoperative cardiac surgical intensive care unit in critical condition.The patient developed diffuse cerebral edema postoperatively and expired on pod#4.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA
• Manufacturer Contact: gail warner ; 1 edwards way; ant 6.1; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12566054
• Report Number: 2015691-2021-05486
• Device Sequence Number: 11136601
• Product Code: DYE
• UDI-Device Identifier: 00690103152678
• UDI-Public: (01)00690103152678(17)200514
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: 6900P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female