MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL MEMO 3D SEMIRIGID ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING

Model Number	SMD30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dhr review has been completed.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.Unknown device disposition.
Event or Problem Description
The manufacture was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a memo 3d #30 device was implanted and explanted on the same day on (b)(6) 2021.Another memo 3d #30 was finally implanted.No further information about any device malfunction or patient outcome was received from the site regarding this event.
Additional Manufacturer Narrative
The manufacturer attempted to retrieve additional information on the event and on the device disposition after the failure to implant experienced.However, no additional information has been received to date.Based on the limited information available, it is not possible to establish a definitive root cause on the reported event.However, from the document review performed, no manufacturing deficits were identified.Should any further information be received in the future, the manufacturer will provide an update to this reporting activity.H3 other text: unknown device disposition.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11605937
• Report Number: 3005687633-2021-00109
• Device Sequence Number: 19868241
• Product Code: KRH
• UDI-Device Identifier: 08022057013125
• UDI-Public: (01)08022057013125(240)ICV0969(17)250815
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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: 08/15/2025
• Device Model Number: SMD30
• Device Catalogue Number: ICV0969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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: 65 YR