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

Model Number PVS27

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/01/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Device was not returned from the site.

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.

• 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: roberta lamberti ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 15287295
• MDR Text Key: 298561911
• Report Number: 3004478276-2022-00179
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000443
• UDI-Public: (01)00896208000443(240)ICV1211(17)230923
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 61 KG