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

Model Number	F7-027
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Incomplete Coaptation (2507)
Health Effect - Clinical Code	Mitral Insufficiency (1963)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not yet returned to manufacturer.
Event or Problem Description
On (b)(6) 2018 a patient was treated for recent mitral insufficiency with percutaneous transluminal angioplasty to lad and new onset severe mitral regurgitation and partial la septum (cor-triatriatum).The patient underwent a cabg to lad, excision of the partial septum in the left atrium and mitral valve replacement.The site used a carbomedics optiform f7-027, sn: (b)(4), mechanical valve seated in the supra annular position.The leaflets were check and movement was confirmed.After coming off cpb prior to closure an occasional asynchronous movement in one of the leaflets was detected via trans-oesophageal echo (toe).The patient was placed back on cpb and the valve was inspected.No issues were found and no mechanical hinderance was visible from any surrounding tissue.The patient was taken off cpb and toe was performed.The same issue was observed.The site then removed the carbomedics device and implanted a ttk chitra 27 valve.The site reported profuse bleeding due to the long procedure times and transfusion required.
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.
Additional Manufacturer Narrative
The manufacturer has not received back the device in question and therefore cannot perform any additional investigations regarding the reported adverse event.Based on the information initially reported it is not possible to determine a root cause for the reported leaflet dysfunction.In addition the site reported, "no issues were found and no mechanical hinderance was visible from any surrounding tissue", which indicates there were no observed factors that could have lead to the reported issue.The manufacturer will reassess the investigation if the device in question is received and will conduct all relevant analyses.

• 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
• MDR Report Key: 8149282
• Report Number: 3005687633-2018-00228
• Device Sequence Number: 1961180
• Product Code: LWQ
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)230316
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2019

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: 03/16/2023
• Device Model Number: F7-027
• Device Catalogue Number: CPHV
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 12/16/2018; 02/15/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/15/2019; 02/15/2019
• 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