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  

Manufacturer Narrative

Device not explanted.

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.

Manufacturer Narrative

The manufacturer completed a full analysis of the manufacturing and quality records to further investigate the reported complaint.The results confirmed that the device size is indeed a 25, as correctly reported in the external and internal packaging, except for the id-tag string, that reports 23.This was the only discrepancy detected, and the device otherwise satisfied all material, visual and performance standards required at the time of manufacture and release.As a result of the investigation performed, the root cause has been identified in a human error, during the preparation of id-tag as the data were manually inserted resulting in the wrong size addition.During the following manufacturing step, the error was not intercepted.Based on the investigation performed, the root cause is therefore identified in a manufacturing deficiency.It should be noted that the ifu states that: "verify that all carton and container labels match with respect to valve catalog number, size, and serial number.In the event of any non-matching information, do not use the valve." as reported from the field, the surgeon noted the labeling error but it was decided anyway to implant the device in the patient assuming that the valve was a 25.Therefore, the decision to implant the device in the patient was performed off-label.

• 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: 9517053
• MDR Text Key: 214643666
• Report Number: 3005687633-2019-00274
• 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
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Date Manufacturer Received: 01/08/2020
• 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