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

Model Number	SMD30
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the manufacturer was notified that a memo 3d semirigid ring was attempted to be implanted without success on (b)(6) 2017.Medtronic tissue valve was used instead.Thirty min of extra x-clamp time was added to the procedure.Patient was discharged and is doing well.The surgeon stated that the patient annulus anatomy was not suitable for a valve repair.
Additional Manufacturer Narrative
Corrected data: common device name.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; via crescentino snc; saluggia, vc
• MDR Report Key: 6632593
• Report Number: 3005687633-2017-00060
• Device Sequence Number: 1254816
• Product Code: KRH
• UDI-Device Identifier: 08022057013125
• UDI-Public: (01)08022057013125(240)ICV0969(17)210628
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/09/2017

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: 06/29/2021
• Device Model Number: SMD30
• Device Catalogue Number: ICV0969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 06/09/2017
• 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