MAUDE Adverse Event Report: CORCYM S.R.L. CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; HEART-VALVE, MECHANICAL

Model Number CP-027

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

H3 other text : unknown disposition.

Event Description

Manufacturer was informed of the following event through device tracking department.Reportedly, on 14 jan 2012, a carboseal valsalva valve cp-029 was implanted in a patient.The device was explanted and replaced with a perceval valve pvs27 on (b)(6) 2017.No allegation of any device dysfunction or serious injury on the patient has yet been reported from the site.

Manufacturer Narrative

A complete manufacturing and material records review for the carboseal valsalva cp-027 has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Manufacturer attempted to follow up with field, but no further information has yet been received despite manufacturer's multiple attempts of follow up.Based on the limited information available, the definitive root cause of the reported event cannot be established at this time.However, 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: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vc
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 18414630
• MDR Text Key: 331580860
• Report Number: 3005687633-2023-00132
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013569
• UDI-Public: (01)08022057013569(240)CP-027(17)140501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900060/S024
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Model Number: CP-027
• Device Catalogue Number: CP-027
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2011
• 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: 47 YR
• Patient Sex: Male