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

Model Number	MRCS34
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	06/30/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; strada crescentino snc; saluggia,, vc 13040 ; IT 13040
• MDR Report Key: 6786835
• Report Number: 3005687633-2017-00081
• Device Sequence Number: 16414110
• Product Code: KRH
• UDI-Device Identifier: 08022057015105
• UDI-Public: (01)08022057015105(240)ICV1335(17)220125
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2017

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: Physician
• Device Expiration Date: 01/25/2022
• Device Model Number: MRCS34
• Device Catalogue Number: ICV1335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/10/2017
• 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: 73 YR