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

Model Number	SMD38
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Heart Failure (2206)
Date of Event	08/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer narrative, a memo 3d size 38 was implanted, but severe mitral regurgitation was detected four days later and the patient was re-operated.The original repair was insufficient, and leaflet reconstruction was performed upon explant of the original device.A new memo 3d size 38 was then implanted in place of the original device.The patient required ecmo treatment due to heart failure; however, ecmo was discontinued two days later and the patient is now doing well.This event was deemed to be not-device-related, as it resulted from insufficient repair during the original operation (leaflet reconstruction required, but not performed).As such, no further investigation is necessary, and this case can be closed.
Event or Problem Description
A memo 3d size 38 was implanted on (b)(6) 2017.On (b)(6) 2017, due to a severe, persistent mr, the patient was re-operated.The surgeon removed the ring, performed a leaflet reconstruction, and implanted a new memo 3d size 38.The surgery was minimally invasive.The patient required ecmo treatment due to heart failure.Ecmo was discontinued on (b)(6) 2017, and the patient is now doing well.The manufacturer was notified of this event on 29-aug-2017.

• 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 13040 ; IT 13040
• MDR Report Key: 6891241
• Report Number: 3005687633-2017-00095
• Device Sequence Number: 10790216
• Product Code: KRH
• UDI-Device Identifier: 08022057013163
• UDI-Public: (01)08022057013163(240)ICV0973(17)171015
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Report Date (Section B): 09/26/2017

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: 10/15/2017
• Device Model Number: SMD38
• Device Catalogue Number: ICV0973
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/25/2017
• 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: 44 YR