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

Model Number	SMD26
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	09/14/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Disposition not presently known.
Event or Problem Description
It was reported that a memo3d size 26 was implanted and explanted intraoperatively.No other information was provided.
Additional Manufacturer Narrative
Based on the additional information received, the repair with the annuloplasty ring was converted to a total mitral valve replacement.The information describes a typical operational course, in which a mitral valve repair is attempted, but the patient's specific anatomy precludes adequate repair with an annuloplasty and total valve replacement is required.As reported by the site, the event is related to the patient's specific clinical condition, and is not related to the involved device.The event is therefore deemed not device-related, and no investigation is necessary.Updated fields: not available for return.
Event or Problem Description
It was reported that a memo3d size 26 was implanted and explanted intraoperatively in a patient with rheumatic valve disease.The site indicated that after implanting the memo3d there was still moderate mitral regurgitation on echo.The annuloplasty ring was therefore explanted and replaced with a st.Jude epic valve.There was some procedural delay incurred by returning to bypass; however the specific delay time was not reported.The patent was released to icu per normal procedure.It was reported that there was no fault with the device, and that the event was partly attributable to the patient's rheumatic valve.

• 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, vc 13040 ; IT 13040
• MDR Report Key: 8097954
• Report Number: 3005687633-2018-00217
• Device Sequence Number: 2025262
• Product Code: KRH
• UDI-Device Identifier: 08022057013101
• UDI-Public: (01)08022057013101(240)ICV0967(17)181004
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: 10/04/2018
• Device Model Number: SMD26
• Device Catalogue Number: ICV0967
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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: 78 YR