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 Codes	Endocarditis (1834); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was informed of the following event through device tracking department.Based on the information on patient implant form, on (b)(6) 2023, a perceval plus valve size xl was ''disposed''.Further information from the site confirmed that the device was implanted earlier, and within 2 months post op, a permanent pacemaker was implanted.As pve with severe paravalvular insufficiency, subannular abscess, and disconnection of the av region were developed, the perceval valve was explanted on (b)(6) 2023.Reportedly, while explanting the valve, extensive vegetative material was noted, and endocarditis was extensive.Inspiris valve size 27 was ultimately implanted instead, and the pacemaker was also removed.
Additional Manufacturer Narrative
H3 other text : already disposed by site.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval plus heart valve, model # pvf-xl-us, s/n #(b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model # pvf-xl-us) perceval plus heart valve at the time of manufacture and release.Since the device was not returned to the manufacturer for further investigation, the cause of the reported event cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were noted.Should further information be received in the future, a follow up report will be provided.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 18361141
• Report Number: 3004478276-2023-00214
• Device Sequence Number: 15377754
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)270324
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P150011/S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: 11/20/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• 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: 84 YR
• Patient Sex: Male