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

Model Number	PVS27
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, model # icv1211, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model # icv1211) perceval heart valve at the time of manufacture and release.
Event or Problem Description
The manufacturer was notified that on (b)(6) 2021 a patient was intended to receive a perceval pvs27 as part of an avr.During the setup phase when the valve was being removed from the jar a hair was detected on the either the product or the container.As such the site did not use the valve.The procedure was extended by 30 minutes due to this issue.No further information was received.
Additional Manufacturer Narrative
The manufacturer is providing a clarification received on the prolongation of the surgical procedure.It was confirmed that the delay in the procedure was caused by the need to implant a sutured valve.The remainder of the information and root cause analysis previously submitted remain unchanged.
Event or Problem Description
Regarding the delay in the procedure, it was clarified when the hair was found, a decision was made to implant a sutured valve.As such, the prolongation of the surgery resulted from the time to size and to suture the new valve.There were no difficulty to collapse the perceval valve.
Event or Problem Description
Per additional information received, 40 minutes were added for both surgery and x-clamp time included.Furthermore, according to the surgeon, it was confirmed that the hair was not inside the sealed container according to the surgeon, and the hair come probably from an operator during the valve preparation.The remainder of the information previously submitted remains unchanged.
Additional Manufacturer Narrative
The device was returned to the manufacturer for investigation.After decontamination, a visual inspection was performed and confirmed that the valve had no pre-existing defects.It is possible to confirm the presence of a foreign material (reasonably an eyelash or an eyebrow) in the skirt in proximity of the seam for the tubular closure.The height of each leaflet was verified and resulted in compliance.Based on the additional information received from the field, it was confirmed that the contamination occurred during the preparation of the valve and before the implantation.As such, the root cause of the reported event is attributed to the user.No product deficiencies were identified during the investigations performed.No further investigation are deemed necessary at this time.

• 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
• MDR Report Key: 11742679
• Report Number: 3004478276-2021-00151
• Device Sequence Number: 13777301
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)241108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2021

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: 11/08/2024
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 04/30/2021; 06/01/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/27/2021; 06/30/2021
• 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: Other
• Patient Age: 78 YR