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

Model Number M2-027

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Information (3190)

Event Date 09/09/2018

Event Type  Injury  

Manufacturer Narrative

Device being sent to manufacturer.

Event Description

On (b)(6) 2018 an orbis m2-027 mechanical mitral valve was implanted.It was reported that after one hour one of the leaflets stopped moving.No further information was received.

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 made several attempts to retrieve additional information and to date has not received any additional information.At this time because the device was not available for return and no further information is available the root cause of the reported event cannot be determined.If additional information is received the manufacturer will reassess the investigation.Fields changed: b4, g4, g7, h2, h6.

Manufacturer Narrative

Additional information received on mar.22, 2019.An updated summary has been included below and in section b5.This additional information does not change the original conclusion or analysis results.On (b)(6) 2018 an orbis m2-027 mechanical mitral valve was implanted.It was reported that after one hour one of the leaflets stopped moving as observed by echo.The valve was explanted and a second orbis m2-027 was implanted.No concomitant procedures were performed.The patient had no abnormal geometries and after the redo progressed well with recovery.

Event Description

On (b)(6) 2018 an orbis m2-027 mechanical mitral valve was implanted.It was reported that after one hour one of the leaflets stopped moving as observed by echo.The valve was explanted and a second orbis m2-027 was implanted.No concomitant procedures were performed.The patient had no abnormal geometries and after the redo progressed well with recovery.

• Brand Name: CARBOMEDICS ORBIS PROSTHETIC 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: 7942498
• MDR Text Key: 123052701
• Report Number: 3005687633-2018-00194
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08022057012548
• UDI-Public: (01)08022057012548(240)M2-027(17)230303
• 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,Followup
• Report Date: 04/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: M2-027
• Device Catalogue Number: M2-027
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/08/2018
• Supplement Dates Manufacturer Received: 10/23/2018; 01/18/2019; 03/22/2019
• Supplement Dates FDA Received: 11/21/2018; 01/23/2019; 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR