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); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2021
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 corcym canada corp.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.Since the device was not returned to the manufacturer (disposition unknown at this time), it was not possible to perform additional investigation.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified.The manufacturer will follow up to retrieve additional details on the event.Should further information be received, the manufacturer will provide an update to this reporting activity.Device disposition unknown.
Event or Problem Description
The manufacturer was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a perceval valve model pvs27 was implanted and explanted on the same day on (b)(6) 2021.No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.
Additional Manufacturer Narrative
The manufacturer received additional information as indicated in b5.As reported, the device is available for return.As such, further investigation will be performed upon receipt.
Event or Problem Description
The manufacture was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a perceval valve model pvs27 was implanted and explanted on the same day on (b)(6) 2021.The manufacturer received additional information from the site identifying the following.The patient required aortic valve replacement due to severe calcification of the native valve.The valve was sized for a extra large perceval which was brought to the field.Three guiding sutures were placed at the commissure nadirs and the valve delivered.Positioning appeared excellent with no significant evidence for under oversizing.Per the ifu, balloon dilation of the valve was performed.The aorta was then closed in a double layer fashion.However during the de-airing process, it was noted the valve positioning was extremely altered and was now noted in the left ventricular cavity.It required the patient to be placed on cardio pulmonary bypass again.The perceval valve was retrieved and replaced by another manufacturer' s valve (medtronic avalus 25 mm valve).The patient remained stable during the entire procedure and was on cardiopulmonary bypass at the time of the valve dislodgement.No further events occurred from this situation and the patient recovered.Per tee, the aortic valve was bicuspid and measured at 1.5 cm by planimetry.Per surgeon's notes the as- valve area 0.84.Aortic valve area was estimated to be 2.4 cm squared.No further de-calcification reportedly occurred after the perceval valve explant and the implant of the second prosthesis.As reported, no cpr or other manipulation occurred after implantation of the perceval valve.An echocardiogram done after placement showed a normal functioning valve with only a trace of perivalvular leak and good positioning.After the patient was de-aired and cross-clamp removed in preparation for separation from cardiopulmonary bypass, the valve positioning was altered and noted in the left ventricle.
Additional Manufacturer Narrative
The device was returned to the manufacturer for investigation.The height of each leaflet has been verified and it resulted in conformity.After decontamination, the valve was visually inspected.No element of non-conformity has been highlighted.The dimensional analysis showed absence of dimensional irregularity, confirming that the returned valve meets the specifications required at the time of manufacture and release for a perceval valve model pvs27.Furthermore, a complete manufacturing and material records review for the nitinol component has been performed.The results confirmed that the component satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device.As reported, the patient's native valve was bicuspid, although it was not further specified if it was a congenital bicuspid valve or acquired.It should be noted that the following note of precaution is present in the perceval valve ifu for the use of the perceval valve with congenital bicuspid valve "data from clinical or in vitro testing are not available to establish the safe use of the perceval valve in patients with congenital bicuspid aortic valve.Therefore, careful consideration of its use is recommended in such cases, especially when the depth of the 2 sinuses in the lvot is unequal.".It is possible that the patient's anatomy contributed to the event reported.

• 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, british columbia
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 12021281
• Report Number: 3004478276-2021-00175
• Device Sequence Number: 14588557
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)230917
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• 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: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2021

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: 09/17/2023
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/30/2021; 10/08/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 09/28/2021; 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2020
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Race: White