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

Model Number	PVS27
Medical Device Problem Codes	Perivalvular Leak (1457); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Thrombocytopenia (4431); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, a perceval valve pvs27 was implanted in aortic position.The device was explanted on (b)(6) 2021 due dislodged aortic valve.The patient ultimately received a 25 mm carpentier-edwards valve.No cpr or other manipulation of the heart were performed after the perceval valve implant.The patient was discharged to home on (b)(6) 2021.The device functionality was checked at the time of implant, and postoperatively, with the following findings.From the operational note, it is reported that the valve functioned well with mild periprosthetic leak in the expected location of severe calcification.The intraoperative tee post-bypass showed that a well seated bioprosthetic aortic valve.There was no prosthetic valvular regurgitation and mild-moderate perivalvular regurgitation was present.In the midesophageal aortic valve short axis view this was noted by where the native right coronary cusp and the native right-left cusp junction would lie anatomically.In the midesophageal long axis view, the perivalvular regurgitation was noted along where the valve abuts the interventricular septum.No holodiastolic reversals were noted with pulse wave doppler in the descending thoracic aorta.The mean prosthetic aortic valve systolic gradient was 11.3 mmhg.On (b)(6) 2021, the echo showed significant paravalvular ar, difficult to quantify but likely in the moderate to severe range.Furthermore, the patient's postoperative course was complicated by thrombocytopenia, in rate controlled atrial fibrillation, acute oluguric renal failure.The patient¿s pre-operative platelets count was 211k, drop to 63k on (b)(6) 2021 without bleeding.The platelets count dropped to 23k on (b)(6) 2021, but started to recover on (b)(6) 2021.The patient had no hematological disorders and tested negative for heparine induced thrombocytopenia on (b)(6) 2021.

• Brand Name: PERCEVAL 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
• MDR Report Key: 12869546
• Report Number: 3019892983-2021-01038
• Device Sequence Number: 14890134
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)240317
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2021
• Report Date (Section F): 10/25/2021

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: 03/17/2024
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2021
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male