MAUDE Adverse Event Report: SORIN GROUP USA, INC. MEMO 3D RECHORD; RING, ANNULOPLASTY

Model Number MRCS30

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Mitral Regurgitation (1964)

Event Date 12/22/2016

Event Type  malfunction  

Event Description

Patient had an annuloplasty ring implanted on during mitral valve repair in one year ago.Patient began experiencing symptoms of mitral valve regurgitation again 4 months later.Ct scan imaging indicated that the ring was displaced into the abdominal aorta.No injury associated with displacement.Device has not been explanted to date as patient will require medical optimization prior to repeat surgery.

• Brand Name: MEMO 3D RECHORD
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 6325278
• MDR Text Key: 67232545
• Report Number: 6325278
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MRCS30
• Device Catalogue Number: MRCS30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2017
• Date Report to Manufacturer: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 46 YR
• Patient Weight: 115