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

Model Number CP-023

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 255481930
• Report Number: 3005687633-2021-00107
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057013545
• UDI-Public: (01)08022057013545(240)CP-023(17)210531
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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): Other
• Patient Age: 57 YR
• Patient Sex: Male