MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING

Model Number MRCS38

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Endocarditis (1834)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

Device not available for return.

Event Description

The manufacturer was notified about the dehiscence of a memo 3d annuloplasty ring.The ring has been explanted, and was replaced with a 36 mm physio ii ring.It was reported that a smaller physio ring may have provided better coaptation.The patient was discharged safely.There were no structural ring defects and sutures had pulled out of posterior annular tissues.It was reported that there were no microorganisms on microscopy, nothing on gram stain, and nothing on direct culture.Staph epidermidis was identified on enrichment culture.No mycobacterial culture was requested.It was reported that the annuloplasty ring have now been destroyed and not available for return.

Event Description

A memo-3d was implanted on (b)(6) 2017.The patient had posterior mitral valve prolapse and no regurgitation or systolic anterior motion (sam) at the end of the procedure.On (b)(6) 2017, the ring was explanted for dehiscence of the annuloplasty ring.The ring has been explanted, and was replaced with a 36 mm physio ii ring.It was reported that a smaller physio ring may have provided better coaptation.The patient was discharged safely.There were no structural ring defects and sutures had pulled out of posterior annular tissues.It was reported that there were no microorganisms on microscopy, nothing on gram stain, and nothing on direct culture.Staph epidermidis was identified on enrichment culture.No mycobacterial culture was requested.It was reported that the annuloplasty ring have now been destroyed and not available for return.The patient did well following the re-operation, although the operation was challenging.

Manufacturer Narrative

Additional information: patient outcome after initial operation and re-operation.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Type of Device: MEMO 3D RECHORD
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7315331
• MDR Text Key: 101563002
• Report Number: 3005687633-2018-00122
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K071327
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Model Number: MRCS38
• Device Catalogue Number: ICV1337
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention