MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS KONECT RESILIA AORTIC VALVED CONDUIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	11060A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: 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
It was learned through implant patient registry that a 29mm 11060a aortic valved conduit was explanted after an implant duration of one (1) year and four (4) months due to unknown reason.The explanted device was replaced with a 27mm 11060a aortic valved conduit.The patient was in recovery post procedure.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
H11: additional manufacturer narrative: updated: b4, g3, g6, h2, h6 (component code, type of investigation, investigation findings, investigation conclusions) due diligence attempts were made to gather additional information regarding a device failure mode, however additional information is not available at this time.Patient medical records were not provided by the hospital for review, or the medical records provided do not clarify the device failure mode.In this case, there is no evidence of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.The device history record (dhr) was not reviewed as no information regarding a device failure mode was provided.Therefore, a review of manufacturing and/or device component issues that may have contributed to the reported event is unable to be performed.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, b5, g3, g6, h2.H11: corrected data based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
It was learned through implant patient registry and medical records that a 29mm 11060a aortic valved conduit was explanted after an implant duration of one (1) year and four (4) months due to endocarditis.The patient presented with daily fevers and chills.The explanted device was replaced with a 27mm 11060a aortic valved conduit.The patient was in recovery post procedure.Per medical records, the patient tested positive for bacteremia with gamella haemolysans.Intraoperatively, there was no evidence of infection in the ascending aortic graft.Infection was limited on the aortic valve.Initially the annulus was sized to a 25mm inspiris valve which was sutured and secured with a core knot device.Upon coming off cpb, pulsatile bleeding was noted from the area where the pledgeted stitch was removed.Surgeon noted that there was likelihood that the suture must have pulled through.Previous graft (entire root) was resected, and surrounding scar material was resected.The surgeon opted to replace the inspiris with a 27mm 11060a valved conduit.There was difficulty mobilizing the lca due to adherence to the pa.The patient was weaned from cpd without issue and transported back to cvicu in critical but stable condition.Patient discharged on pod#9.Per pathology report, the explanted device was found to have large vegetation, consistent with infective endocarditis.The valve was also noted to have significant necrosis and inflammation.

• Brand Name: EDWARDS KONECT RESILIA AORTIC VALVED CONDUIT
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20446485
• Report Number: 2015691-2024-07826
• Device Sequence Number: 15499806
• Product Code: LWR
• UDI-Device Identifier: 00690103201406
• UDI-Public: (01)00690103201406(17)250214
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2024

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 Expiration Date: 02/14/2025
• Device Model Number: 11060A
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 11/19/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/18/2024; 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male