MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL OPTIFORM PROSTHETIC MITRAL HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number CPHV

Device Problem Difficult to Open or Close (2921)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 09/22/2020

Event Type  Injury  

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 device reported in the event was returned to the manufacturer and it was received on 22 oct 2020.Further investigation is ongoing.

Event Description

The manufacturer has received a customer complaint about a carbomedics optiform mitral valve size 29 (f7-029).It was reported that the valve would not open properly after implantation and was substituted with a size 27.Per additional information received, the patient went for surgery due to subvalvular stenosis and mitral insufficiency.After implantation of the f7-029 and weaning from bypass, one leaflet of the f7-029 did not open.Bypass was re-started and after reopening, the inspection of valve showed no failures.After turning the valve, revising bulgy areas to prevent valve leaflet obstruction, the patient came off pump but still one leaflet did not open.The bypass was restarted again, and the f7-029 was replaced with the smaller size f7-027.The valve functioned well.Closing.The patient started leaking from the old freestyle graft, re-surgery, av block, cardiac massage, av- rupture, ecmo, ischemia, cardiac syndrome, icu neural infarcts, bleeding.The patient passed away on (b)(6) 2020 (as reported, neither valves were suspected as contributory cause of the patient's death).

Event Description

The manufacturer has received a customer complaint about a carbomedics optiform mitral valve size 29 (f7-029).It was reported that the valve would not open properly after implantation and was substituted with a size 27.Per additional information received, the patient went for surgery due to subvalvular stenosis and mitral insufficiency.After implantation of the f7-029 and weaning from bypass, one leaflet of the f7-029 did not open.Bypass was re-started and after reopening, the inspection of valve showed no failures.After turning the valve, revising bulgy areas to prevent valve leaflet obstruction, the patient came off pump but still one leaflet did not open.The bypass was restarted again, and the f7-029 was replaced with the smaller size f7-027.The valve functioned well and the procedure was completed.The patient started leaking from the old freestyle graft, thus re-surgery was performed.These events followed: av block, cardiac massage, av- rupture, ecmo, ischemia, cardiac syndrome, icu neural infarcts, bleeding.The patient passed away on (b)(6) 2020 (as reported, neither valves were suspected as contributory cause of the patient's death).Based on the medical judgment received on the reported event, no defects on the mechanical valve were found.The challenge and the intraoperative dysfunction might very well be of a technical, operative challenge, because it was not possible to identify defects on the mechanical valve before and after implantation.

Manufacturer Narrative

The carbomedics optiform mitral valve f7-029 was returned for analysis.The inspections performed on the returned valve confirmed the absence of manufacturing defects.Little clotted blood residue were identified on the returned prosthesis, which were present also after the decontamination of the device.No functional anomalies were observed during the open/close cycles recorded during the kinematic tests carried out on the cphv subassembly #29 of the valve model f7-029 sn (b)(6).The valve showed a correct movement of the leaflets during opening and closure phases.No anomalies were observed both in normotensive and in hypotensive conditions.Based on the performed analysis, the reported issue is not related to the device quality.It is not possible to exclude a possible leaflets impingement / interference with anatomical components (papillary muscles or chordae tendineae).At the same time, although the blood residues found and documented on the valve are reasonably linked to a post explant state, it is also not possible to totally exclude that in part they may have formed without being undetected during the implanting steps.Thus, it is not possible to totally exclude that undetected blood clotted residual on the leaflet surface in correspondence of hinges cavities could have contributed to the observed leaflets hypomobility as well.Based on the investigation performed and information received, the root cause of the reported hypomobility can be reasonably traced to procedural factors.

• Brand Name: OPTIFORM PROSTHETIC MITRAL HEART VALVE
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10796468
• MDR Text Key: 215288058
• Report Number: 3005687633-2020-00146
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012869
• UDI-Public: (01)08022057012869(240)F7-029(17)241006
• 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
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CPHV
• Device Catalogue Number: F7-029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 113