MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS; HEART VALVE, MECHANICAL

Model Number	CP-023
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).In fact, there was patient involvement as the device in question was implanted, but there is no adverse event or other heath consequences for the patient.The inspection performed on the returned product (sn not object of this report) revealed that the labels on the carton box, on the aluminum pouch and inside the aluminum pouch consistently indicate the same serial number.The label (id tag) attached on the cuff of the prosthesis is also consistent with the serial number shown on the external carton box.However, the documents inside the carton box (i.E.Registration form, labels for clinical use, patient card) indicate a different serial number, the same as the one appearing implanted in the patient from the medical records.The device history records (dhr) reviews for both serial numbers involved (the returned device and the implanted device).The results confirmed that both devices satisfied all material, visual and performance standards required at the time of manufacture and release.Further verification of the re-packaging documents indicate that both devices were returned by finished goods warehouse to be repackaged.Considering the evidence of the product returned and the results of the dhr performed, it is possible that during the manual repackaging, the documents inside the cartons could have been inadvertently interchanged.Further investigation is ongoing.
Event or Problem Description
On (b)(6) 2021, the manufacturer became aware of a product mis-labelling with a livanova device.In particular, a carboseal device model cp-023 was implanted in a patient.However, the serial number of the device that appears in the patient's registration form is not the same as the serial number appearing on the medical records of the hospital.Furthermore, the device model cp-023 with the same serial number showed on the patient's implant card was returned to the manufacturer as expired and not used for any implant.
Additional Manufacturer Narrative
Corrected codes in h6 according to the information previously shared.No more information is available, thus the narrative provided previously remains unchanged.

• Brand Name: CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS
• Common Device Name: HEART VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 11579914
• Report Number: 3005687633-2021-00107
• Device Sequence Number: 17231332
• Product Code: LWQ
• UDI-Device Identifier: 08022057013545
• UDI-Public: (01)08022057013545(240)CP-023(17)210531
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P900060/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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: 05/31/2021
• Device Model Number: CP-023
• Device Catalogue Number: CP-023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male