MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-XL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.The manufacturer is following up with the site to retrieve additional information on the event and the device involved.A follow up report will be submitted upon receipt of any new information or at the conclusion of the investigation.
Event or Problem Description
The manufacturer was informed through mantra study of a perceval plus valve explant occurred less than 2 months after implant.As per information available, the device had been implanted on (b)(6) 2024 through median sternotomy in a patient with a steno-insufficient tricuspid aortic valve with degenerative etiology.Cabg (2 vessels) and atrial appendage excision/clipping for af treatment were performed as concomitant surgery prior to perceval valve implant.Cpb time was 2 hours and cross-clamp time approx.90 minutes.The patient was hospitalized for 1 month prior to be discharged to rehab facility.Perceval valve functionality was good at the echo evaluation performed pre-discharge.As per information received, the patient was re-admitted to hospital due to multivalve endocarditis (mitral, tricuspid and aortic valve prosthesis) and the perceval valve was explanted and replaced with a bioprosthesis from a different manufacturer (medtronic freestyle prosthesis size 25).Additional medical treatment was required (blood transfusion and dialysis).As per additional information received, the bacteria isolated in the microbiological tests was enterococcus faecalis.The site assessed the event as probably related to the device and to other medical conditions and possibly related to initial implant procedure and primary condition being treated.
Additional Manufacturer Narrative
Since the device was not returned for analysis, the manufacturer could not perform further investigation on the explanted prosthesis.Based on the available information, it is not possible to determine a definitive root cause for the reported event.However, it should be considered that the patient suffered from atrial fibrillation as an intrinsic risk factor for endocarditis and was exposed to several external risk factors, namely extended surgical time (approximately 4 hours) due to multiple concomitant procedures performed at the time of perceval implant, extended length of stay (about 6 weeks) plus additional leg surgery during hospitalization.At the same time, it should be noted that no manufacturing, nor sterilization or quality deficits were identified from the analysis of production records performed related to the perceval valve involved in this event.While a definite root cause for the reported event cannot be established, it should be considered that endocarditis is a known, inherent risk associated with cardiac valve replacement with a bioprosthesis and the related surgical procedure, and it is listed among the potential adverse events in the perceval plus ifu.
Event or Problem Description
The manufacturer was informed through mantra study of a perceval plus valve explant occurred less than 2 months after implant.As per information available, the device had been implanted on (b)(6) 2024 through median sternotomy in a patient with a steno-insufficient tricuspid aortic valve with degenerative etiology.Cabg (2 vessels) and atrial appendage excision/clipping for af treatment were performed as concomitant surgery prior to perceval valve implant.Cpb time was 2 hours and cross-clamp time approx.90 minutes.Post-surgery, the patient was hospitalized for about six weeks.As per information received from the healthcare facility, this prolonged hospitalisation was due partly due to a leg hematoma which required surgical treatment and rehab facility unavailability.The patient was discharged to a rehab facility on (b)(6) 2024, with good perceval valve functionality at the echo evaluation performed pre-discharge.As per information received, the patient was re-admitted to hospital due to multivalve endocarditis (mitral, tricuspid and aortic valve prosthesis) and the perceval valve was explanted and replaced with a bioprosthesis from a different manufacturer (medtronic freestyle prosthesis size 25) on (b)(6) 2024.Additional medical treatment was required (blood transfusion and dialysis).As per additional information received, the bacteria isolated in the microbiological tests was enterococcus faecalis.Based on further information received, after the re-do surgery the patient stayed in the hospital until (b)(6) 2024 and was then transferred to another hospital and discharged home in good condition on (b)(6) 2024.The site assessed the event as probably related to the device and to other medical conditions and possibly related to initial implant procedure and primary condition being treated.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 19784907
• Report Number: 3004478276-2024-00153
• Device Sequence Number: 20996291
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)270611
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150011S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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 Model Number: PVF-XL
• Device Catalogue Number: PVF-XL
• 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: 06/22/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 72 KG