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

Model Number	11060A
Medical Device Problem Codes	Microbial Contamination of Device (2303); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endocarditis (1834); Insufficient Information (4580)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through implant patient registry that a 27mm 11060a aortic valve was explanted and replaced with a 25mm 11060a aortic valve after an implant duration of one (1) year, 4 months and 21 days due to unknown reason.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: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Additional Manufacturer Narrative
Updated sections: b4, b5, b7, g3, g6, h2, h6 (clinical code, device code, and type of investigation).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 that a 27mm 11060a aortic valve was explanted and replaced with a 25mm 11060a aortic valve after an implant duration of one (1) year, 4 months and 21 days due to strep a bacteremia endocarditis with periaortic root abscess.The patient presented with abdominal pain and chest pain.The patient was transported while intubated to the icu in critical condition.Per medical records, patient presented with chest pain in multisystem organ failure and group a strep bacteremia in the setting of a recent tooth infection.The patient was admitted to icu due to unstable hemodynamics, chb, and iv antibiotic administration per infectious disease.Tee demonstrated periaortic abscess without evidence of vegetation or valvular dysfunction.Intraoperatively, significant inflammation and phlegmonous changes were noted near the aortic root.There was extensive destruction of the aortic root graft material and infected tissue was removed.There was no obvious purulent material.A 25mm 11060a valved conduit was secured.The patient was weaned from bypass and sent to the icu in critical condition.Post-op tee showed well-seated aortic valve with mean gradient of 15mmhg.Per pathology, excised aortic root had scant amount of attached pink-tan, soft rubbery tissue.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 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: 19547138
• Report Number: 2015691-2024-04645
• Device Sequence Number: 15136133
• Product Code: LWR
• UDI-Device Identifier: 00690103201390
• UDI-Public: (01)00690103201390(17)240322
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 07/12/2024

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: 03/22/2024
• Device Model Number: 11060A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2022
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male