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

Model Number MRCS34

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Mitral Regurgitation (1964)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

As per medical judgment the physician has indicated that this was a sizing issue and that the event was not device related.Device not returned to manufacturer.

Event Description

On (b)(6) 2017 the manufacturer was notified through patient tracking of a memo 3d rechord semirigid annuloplasty ring that was implanted/explanted on (b)(6) 2017.Further information from the physician informed the manufacturer that the ring was implanted on (b)(6), during the procedure when the patient was coming off the pump, systolic anterior motion (sam) on echo was observed.The physician decided to put the patient back on pump and explant the device.A medtronic cg future band size 36 was then implanted.The patient is doing well following the surgery.An additional x clamp time of approx 20-30 minutes was added to the procedure.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada crescentino snc; saluggia,, vc 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia,, vc 13040 ; IT 13040
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 6786835
• MDR Text Key: 82463859
• Report Number: 3005687633-2017-00081
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057015105
• UDI-Public: (01)08022057015105(240)ICV1335(17)220125
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/25/2022
• Device Model Number: MRCS34
• Device Catalogue Number: ICV1335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR