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

Model Number F7-027

Device Problems Material Too Rigid or Stiff (1544); Incomplete Coaptation (2507)

Patient Problem Mitral Insufficiency (1963)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Device not yet returned to manufacturer.

Event 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.

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.

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
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8149282
• MDR Text Key: 129875339
• Report Number: 3005687633-2018-00228
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012852
• UDI-Public: (01)08022057012852(240)F7-027(17)230316
• Combination Product (y/n): N
• PMA/PMN Number: P900060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention