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

Model Number	PVS25
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, after a perceval valve size m was implanted and explanted intra-operatively in the patient whose native valve was bicuspid type 1 due to pvl noted and low blood pressure (ref.(b)(4)), perceval valve size l (this case) was implanted in the patient.However, it was reported that the valve was slightly popped up since the non-coronary part was protruded.As such, this valve was also explanted and epic (unknown size) was ultimately implanted in the patient.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h6.A follow up report will be provided upon receipt of further information or completion of any investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h3, h6.The manufacturer attempted to retrieve further information regarding this event, but no further information was provided despite manufacturer's multiple attempts of follow up.The manufacturing and material records for the perceval heart valve, model #icv1210, s/n # (b)(6) as they pertain to the reported event, were retrieved and reviewed by a manufacture¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a (model #icv1210) perceval heart valve at the time of manufacture and release.The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without observing any macroscopic anomalies and/or pre-existing defects according to the specifications.During the simulation, in silicon aortic roots #23 and #25, no problems were encountered during the deployment and the ballooning phase.The positioning at the annulus level is reasonably stable as visible in the attached pictures, and the valve remained fixed within the annulus.Then, inserting some water in the aortic root from the outflow side, no paravalvular leaks were observed during the simulations.Considering the static conditions of the test the water level remained stable under the leaflets free edge.Based on the performed analyses, the reported event cannot be explained by any factor intrinsic in the involved device and it is possible to exclude the relationship between the reported issue and the returned device quality.The deployment simulation, performed on the returned valve, did not highlight anomalies and the valve resulted globally well deployed and fixed in stable way.Furthermore, 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 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: 17295103
• Report Number: 3004478276-2023-00161
• Device Sequence Number: 3875231
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)231127
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 09/01/2023

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: 11/27/2023
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 08/03/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/17/2023; 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2020
• 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 Sex: Male