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

Model Number PVS25

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Tavr was performed.

Event Description

The manufacturer was informed that on (b)(6) 2022, a perceval sutureless aortic heart valve size 25 was implanted on a patient to replace a native bicuspid aortic valve.Reportedly, during the procedure, they had a very poor visibility with a pliable graph also obstructing their view and a traditional valve would not have worked, medical professionals believed that perceval was the best choice of valve.On (b)(6) 2022, few days post-surgery the patient's echo showed pvl on two sides.Following a post-op ct the patient was taken to the cath lab where it was confirmed the perceval had migrated and was tilted slightly.As such, a tavr was performed.Patient recovered well and both the perceval and tavr has been working well, and no pvl was noticed.Reportedly, patient was doing well and was discharged.Based on the medical judgement received, this was a difficult case that would have been tricky regardless of which valve was used on the day.The patient has a history of bicuspid native aortic valve with previous ascending aorta replacement approximately 7 years ago prior to avr with perceval.Ar and some as were noted prior to avr, as further reported.The manufacturer was informed that no further information will be provided.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h6.Since the serial number of the device is unknown and the device remained implanted, no further investigation on the device can be performed at this time.As such, the definitive root cause of the reported event cannot be established.Based on the medical judgment received, ''this was a difficult case that would have been tricky regardless of which valve was used on the day''.As such, the cause of the event can reasonably be traced to the patient condition.Should further information be received in the future, a follow up report will be provided.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: 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: 16661323
• MDR Text Key: 312493498
• Report Number: 3004478276-2023-00131
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female