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

Model Number	SMD34
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location not presently known.
Event or Problem Description
On (b)(6) 2019, a memo 3d smd34 icv0971 implant attempt occurred.However, it is reported that the device was implanted and explanted during the procedure.No further information on this event has been received.
Event or Problem Description
On (b)(6) 2019, a memo 3d smd34 icv0971 implant attempt occurred.However, it is reported that the device was implanted and explanted during the procedure.Despite the attempted follow up, no further information on this event has been received.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Since the device was not returned to the manufacturer, no further investigation can be performed at this time.Based on the limited information available, it is not possible to establish the root cause of the reported explant.However, the document review did not highlight any manufacturing deficit for the device.If additional information will be received, a follow up report will be submitted.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8438936
• Report Number: 3005687633-2019-00156
• Device Sequence Number: 2242289
• Product Code: KRH
• UDI-Device Identifier: 08022057013149
• UDI-Public: (01)08022057013149(240)ICV0971(17)211227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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: Health Professional
• Device Expiration Date: 12/27/2021
• Device Model Number: SMD34
• Device Catalogue Number: ICV0971
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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: Other
• Patient Age: 66 YR