MAUDE Adverse Event Report: SORIN GROUP ITALIA MEMO 3D; MEMO 3D SIZE 32

Model Number	SMD32
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	08/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We acknowledge late reporting of this case due to the fact that the information was received from patient tracking form on september 15th, 2016, however, more details about the explant was received on september 29th, 2016.(b)(6) is reporting this case in conservative manner, since relationship with the device is still not clear.The manufacturer is still trying to obtain more information.The review of the device history record is ongoing.
Event or Problem Description
Pt (b)(6) received a prf for a mitral ring smd32 sn # (b)(4) which was removed on (b)(6) 2016 at (b)(6) medical center.Patient (b)(6) is male, dob (b)(6) 1947.Update from sales 29 sept 2016: dr (b)(6) was operating surgeon.He placed the 32 ring into the patient.When coming off bypass and post tee performed, severe mr was noted.Went back onto bypass, removed the ring and replaced with an edward's tissue valve.Patient had an extended post op recovery including long intubation time, post op acute renal failure, elevated liver functions and a stroke.Patient was discharged after 14 days to a rehab facility.
Additional Manufacturer Narrative
Corrections: typo in the initial - indicated "dr.(b)(6)".The correct surgeon ref.Is "dr.(b)(6)".In the initial: indicated "replace" per misinterpretation of the meaning.Update: review of the data filed in the device history record confirmed that this annuloplasty ring satisfied all material, dimensional and performance standards required for a memo 3d - semirigid mitral annuloplastic ring 32 at the time of manufacture and release.Device not available.

• Brand Name: MEMO 3D
• Common Device Name: MEMO 3D SIZE 32
• Manufacturer (Section D): SORIN GROUP ITALIA; via crescentino sn; saluggia, 13040 ; IT 13040
• MDR Report Key: 6041602
• Report Number: 3005687633-2016-00019
• Device Sequence Number: 76994
• Product Code: KRH
• UDI-Device Identifier: 08022057013132
• UDI-Public: (01)08022057013132(240)ICV0970(17)200816
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2016

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: No Information
• Device Expiration Date: 08/16/2020
• Device Model Number: SMD32
• Device Catalogue Number: ICV0970
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2016
• Supplement Report FDA Received Date: 12/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR