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

Model Number	PVS27
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that percival heart valve size 27 was implanted and explanted intra-operatively on (b)(6) 2022.Reportedly, the annulus diameter was 28.8mm on preoperative ct.During the sizing procedure, the xl white obturator was moderately resistant, so the xl size valve was implanted.However, after de-clamp, echo showed paravalvular leakage.After re-clamp, it was found that the part of the device has fallen to the lvot side.As such, device was explanted and epic 27mm was implanted instead.Based on the medical judgement received, the fall of the device was probably due to a larger native annulus.More than 20 minutes was added to the cross clamp time as a result of the reported event.Based on the information received, there was no concomitant procedure and echo is unavailable.There was no positioning difficulty, no abnormal geometry in the patient's annulus, and no problem with the device functionality.
Additional Manufacturer Narrative
Device was not returned from the site.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, model #icv1211 , s/n #(b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.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.
Additional Manufacturer Narrative
Updated sections b4, g3, g6, h2, h6, h11.The manufacturing and material records for the perceval heart valve, model #icv1211, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.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.Based on the available information, there was no positioning difficulty, no abnormal geometry in the patient's annulus, and no problem with the device functionality.Further, no deficits were noted during the production records review.Since device is not available for return as indicated by the site, no other investigation can be performed, and the root cause remains undetermined.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: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 15287295
• Report Number: 3004478276-2022-00179
• Device Sequence Number: 2406990
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)230923
• 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: 2022
• Device Explanted Year: 2022
• 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): 02/24/2026

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: 09/23/2023
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• Was Device Available for Evaluation?: No
• 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: 08/01/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 02/24/2026
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/26/2022; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 61 KG