MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS

Model Number A5-025

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019, a carbomedics standard aortic was intended to be implanted in a patient.Upon inspection of the device after the opening of the box, it was identified that the size on the label tag of the device (i.E.23) did not match with the size on the box (i.E.A5-025).Since the serial number of the tag matched the one on the valve box, the surgeon decided to implant the device in the patient assuming that it is a size 25.Despite the labeling discrepancy, no other perceived issues with the device are reported.The procedure was successfully completed using this valve.The patient was not adversely impacted by this event.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9517036
• MDR Text Key: 176576091
• Report Number: 1718850-2019-01220
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012630
• UDI-Public: (01)08022057012630(240)A5-025(17)230916
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 11/26/2019,02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2023
• Device Model Number: A5-025
• Device Catalogue Number: A5-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2019
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 75