MAUDE Adverse Event Report: CORCYM S.R.L. PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVF-S
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of the following event through received mantra study database.Based on the information received, on 12 dec 2022, small perceval plus valve was implanted in the patient.The surgical approach was mini thoracotomy and there was no concomitant procedure performed.The site reported asystole on (b)(6) 2022 which led to 12 seconds of cardiac massage.Furthermore, a conduction disturbance that started on (b)(6) 2022 was also reported which required a temporary pacemaker to be inserted.Based on the information received, a permanent pacemaker was eventually implanted on (b)(6) 2022 to address the complete av block.The outcome was indicated as recovered/resolved.Based on the information available in the database, patient had a history of arrhythmia (sinus arrhythmia), cardiac conduction disorder, stroke, and peripheral vascular disease (carotid artery disease).
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the available information, it is not possible to draw a definitive root cause on the reported event.However, based on the document review performed, no manufacturing deficiencies were identified.Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease and preoperative aortic regurgitation.This event is, therefore, a known, inherent risk of the procedure, and it is listed among the potential adverse events in the perceval plus ifu.Device remained implanted.

• Brand Name: PERCEVAL PLUS SUTRUELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 16244687
• Report Number: 3005687633-2023-00097
• Device Sequence Number: 12400190
• Product Code: LWR
• UDI-Device Identifier: 08022057015365
• UDI-Public: (01)08022057015365(240)PVF-S(17)260914
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P15011/S013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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: 09/14/2026
• Device Model Number: PVF-S
• Device Catalogue Number: PVF-S
• 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: 12/27/2022
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Female