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

Model Number	A5-025
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not explanted.
Event or Problem 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.
Additional 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
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9517053
• Report Number: 3005687633-2019-00274
• Device Sequence Number: 3461711
• Product Code: LWQ
• UDI-Device Identifier: 08022057012630
• UDI-Public: (01)08022057012630(240)A5-025(17)230916
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Weight: 75