MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. OPTIFORM PROSTHETIC MITRAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	F7
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
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 reported information, the valve dysfunction was resolved with heparin.The event can therefore reasonably be attributed to patient and procedural factors associated with the anticoagulation therapy administered.However, as the device was not received for analysis and limited information was provided, this cannot be definitively confirmed.Device evaluated by mfr: not explanted.
Event or Problem Description
A carbomedics optiform mitral valve was implanted.After removing the cross-clamp, echo revealed that the leaflets were stuck.Cross-clamp was resumed, the valve was rotated 90 degrees, and the leaflets were tested.After coming off pump, initially the valve appeared functional; however, the dysfunction recurred.2 hours post-operatively, the dysfunction was reportedly resolved with heparin.It was also reported that the patient's heart was muscular, and may have affected the blood flow.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 8685468
• Report Number: 3005687633-2019-00189
• Device Sequence Number: 11288403
• Product Code: LWQ
• UDI-Device Identifier: 08022057012869
• UDI-Public: (01)08022057012869(240)F7-029(17)191013
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

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: 10/13/2019
• Device Model Number: F7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/10/2019
• 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: 58 YR