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

Model Number PVF-XL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Heart Block (4444)

Event Date 04/27/2023

Event Type  Injury  

Event Description

The manufacturer was informed of the following event through mantra study.Reportedly, perceval plus size xl was implanted in the patient on (b)(6) 2023.Based on information received, patient had complete heart block on (b)(6) 2023 which required a permanent pacemaker to be inserted on the same day.Reportedly, patient has recovered, and the event has resolved.Based on the information available, patient has a history of coronary artery disease, systemic hypertension, dyslipidemia, stroke, renal insufficiency / renal disorder without any dialysis ongoing; sleep apnea, nyha class ii.Furthermore, patient underwent coronary artery bypass graft (cabg) in 2014.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 17014906
• MDR Text Key: 316092297
• Report Number: 3019892983-2023-01014
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)261209
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2023,05/26/2023

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
• Device Operator: 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
• Distributor Facility Aware Date: 04/28/2023
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 76 KG