MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. CARBOMEDICS TOP HAT MECHANICAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	S5-023
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, it is not possible to establish a definitive root cause for the reported event.Since a smaller size was ultimately implanted, it is possible that the a mis-sizing contributed to the event.However, given that no additional information on the procedure was received, this cannot be ultimately confirmed.There has been no allegation of device malfunction and no formal complaint from the site has been received.If additional information will be received, a follow up report will be submitted.Disposition unknown,unable to follow up.
Event or Problem Description
The manufacturer was informed by the device tracking department that a top hat s5-023 was implanted and explanted on (b)(6) 2019.The patient ultimately received a top hat s5-021.Additional information received from the site confirmed that the patient had a bicuspid aortic valve, ascending aortic aneurysm and symptomatic calcific aortic stenosis.No information on the reason for the intraoperative explant or on the patient outcome was provided.
Event or Problem Description
The manufacturer was informed by the device tracking department that a top hat s5-023 was implanted and explanted on (b)(6) 2019.The patient ultimately received a top hat s5-021.Additional information received from the site confirmed that the patient had a bicuspid aortic valve, ascending aortic aneurysm and symptomatic calcific aortic stenosis.No information on the reason for the intraoperative explant was provided.
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.Based on the available information, it is not possible to establish a definite root cause for the reported event.However, based on the documents review performed, no manufacturing deficits were identified.Since it is reported that the device top hat s5-023 was replaced with a smaller size (top hat s5-021), it is possible that the explant was due to an initial oversizing of the device.Furthermore, the manufacturer did not receive any further complaints or allegations of a device malfunction from the site.Should additional information received in the future, a follow up report will be submitted.

• Brand Name: CARBOMEDICS TOP HAT MECHANICAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 9434574
• Report Number: 3005687633-2019-00268
• Device Sequence Number: 2579326
• Product Code: LWQ
• UDI-Device Identifier: 08022057012913
• UDI-Public: (01)08022057012913(240)S5-023(17)230811
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2019

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: 08/11/2023
• Device Model Number: S5-023
• Device Catalogue Number: S5-023
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 12/31/2019
• 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: 59 YR