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

Model Number TBD

Device Problem Difficult to Open or Close (2921)

Patient Problems Heart Failure (2206); Cardiogenic Shock (2262)

Event Type  Injury  

Manufacturer Narrative

Device disposition presently unknown.

Event Description

The manufacturer was notified of the following publication: cardiovascular flashlight doi:10.1093/eurheartj/ehaa228.Percutaneous transcatheter release of stuckmechanicalmitral valve leaflet yuefeng chen1, ronwaksman 1, lowell satler1, christopher barnett2, andrew chen3, and toby rogers1 1section of interventional cardiology, medstar washington hospital center, 110 irving st.Nw, suite 4b-1, washington, dc 20010, usa; 2section of cardiac critical care, medstar washington hospital center, 110 irving st.Nw, washington, dc 20010, usa; and 3section of cardiac imaging, medstar washington hospital center, 110 irving st.Nw, washington, dc 20010, usa.A (b)(6)-year-old woman with a 29-mm carbomedics mechanical mitral valve (livanova, (b)(4)) was admitted for ongestive heart failure and subsequently developed cardiogenic shock.She was found to have a stuck mechanical mitral valve leaflet (panels a¿c; arrows indicate stuck leaflet; supplementary material online, videos s1 and s2) with severely elevated mean mitral gradient (>30mmhg), and severe pulmonary artery hypertension (123/ 39mmhg, mean 76mmhg).Because the risk of redo surgery was unacceptably high, transcatheter release of the stuck mechanical mitral valve leaflet was attempted.A cerebral embolic protection device (sentinel, boston scientific, marlborough, ma, usa) was positioned in the brachiocephalic and left carotid arteries.The initial attempt to free the stuck leaflet by simply pushing with catheters was unsuccessful.A stiff 0.014inch guidewire (astato xs 20, asahi intecc, japan) was then threaded between the stuck leaflet and the surgical valve ring.The stuck leaflet was successfully pried open with sequential inflations of 1.2-, 2.0-, 3.0-, 4.0-, and 5.0-mm coronary balloons (panels d¿f; arrows indicate guidewire and balloons; supplementary material online, videos s3 and s4).Near-normal motion of both mechanical mitral valve leaflets was achieved (panels g¿i; arrow indicates released leaflet; supplementary material online, videos s5 and s6).Mean left atrial pressure fell from 34 to 13mmhg and mean pulmonary artery pressure fell from 65 to 43mmhg.Substantial thrombus debris was retrieved from the cerebral embolic protection device (panel j).Her clinical status improved, and she was discharged home.

Manufacturer Narrative

The manufacturer made several attempts to follow-up for further information related to the event and no further information was received.At this time since information regarding the individual device is not available no further investigations can be performed.The case will be closed at this time as no further investigation is possible.However, should additional information be provided, the manufacturer will re-assess the event and take further investigative action as applicable.The root cause is thus deemed to be cause not established.

• Brand Name: CARBOMEDICS PROSTHETIC HEART VALVE, MITRAL
• Type of Device: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 10125344
• MDR Text Key: 195627735
• Report Number: 3005687633-2020-00126
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR