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	No Information (3190)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown disposition.
Event or Problem Description
Received information about a carbomedics standard prosthetic aortic heart valve that was implanted on (b)(6) 2019.The device was explanted at around 8 months later on (b)(6) 2020.Other event details including reason of the replacement are still being gathered.
Additional Manufacturer Narrative
The manufacturer is submitting a correction for section g1-2 (contact office - manufacturing site).The remainder of the information previously submitted is unchanged.
Additional Manufacturer Narrative
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.The manufacturer made several attempts to follow-up for further information related to the specific event details and no further information was received.At this time since information regarding the device is not available no further investigations can be performed.The case will be closed at this time as no further investigation is possible.However, should additional information be provided, the manufacturer will re-assess the event and take further investigative action as applicable.The root cause is thus deemed to be cause not established.

• Brand Name: CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, AORTIC
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10383037
• Report Number: 3005687633-2020-00128
• Device Sequence Number: 13885668
• Product Code: LWQ
• UDI-Device Identifier: 08022057012623
• UDI-Public: (01)08022057012623(240)A5-023(17)240119
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020

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: 01/19/2024
• Device Model Number: CPHV
• Device Catalogue Number: A5-023
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 10/13/2020; 11/10/2020
• Initial Report FDA Received Date: 08/08/2020
• Supplement Report FDA Received Date: 11/08/2020; 11/12/2020
• 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: Required Intervention
• Patient Age: 42 YR