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

Model Number	M2-027
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device being sent to manufacturer.
Event or Problem 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.
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 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.
Additional 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 or Problem 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
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 7942498
• Report Number: 3005687633-2018-00194
• Device Sequence Number: 2337560
• Product Code: LWQ
• UDI-Device Identifier: 08022057012548
• UDI-Public: (01)08022057012548(240)M2-027(17)230303
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/23/2018; 01/18/2019; 03/22/2019
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/21/2018; 01/23/2019; 04/17/2019
• 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
• Patient Age: 63 YR