MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC; MECHANICAL HEART VALVE PROSTHESIS

Model Number	CPHV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dhr review has been completed.A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.
Event or Problem Description
The manufacture was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a carbomedics standard aortic valve a5-023 was implanted and explanted on the same day on (b)(6) 2020.No further information about any device malfunction or patient outcome was received from the site regarding this event.
Additional Manufacturer Narrative
Since the device was not returned, no further investigation is possible at this time.Based on the available information, it is not possible to draw a definitive root cause on the reported event, nor to confirm if an event has occurred with the livanova device.In fact, the operational report does not provide evidences on a second device being used and explanted intra-operatively.Furthermore, form the documents received, there is no information on the serial number of the device ultimately implanted in the patient.As such, based on the information available, it is not possible to confirm if the device object of this event was indeed implanted and explanted intra-operatively (and, if so, why) or, rather, if a typo error has been made in the patient registration form received (i.E.Device sn (b)(6) was ultimately correctly implanted).Ultimately, from the document review performed, no manufacturing deficiencies were identified in the device sn (b)(6).The root cause cannot be established.Should further information be available in the future, the manufacturer will provide a follow up to this reporting activity.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11635999
• Report Number: 3005687633-2021-00111
• Device Sequence Number: 3367723
• Product Code: LWQ
• UDI-Device Identifier: 08022057012623
• UDI-Public: (01)08022057012623(240)A5-023(17)240316
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2024
• Device Model Number: CPHV
• Device Catalogue Number: A5-023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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: Required Intervention
• Patient Age: 60 YR