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

Model Number	MRCS30
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/19/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The memo 3d device was explanted intra-operatively and replaced with a carbomedics mitral valve.The patient death was deemed not device related per medical judgement.The investigations will be performed to analyze the reason for explant of the mitral repair ring and are not related to the patient outcome.Device disposed of by hospital.
Event or Problem Description
A patient came with severe heart failure and pulmonary edema required a mitral repair surgery.A repair of the mitral valve was performed using the memo 3d rechord and an artificial chord tied to the chordal guiding system to replace a chordae.Once this was tied it was noted that the yellow loop of the chordal guiding system looked "pulled down" and the chord appeared to be too short.The surgeon decided to then remove the memo 3d rechord.The procedure was changed from a mitral repair to a full mitral valve replacement.The valve was replaced with a carbomedics standard mitral valve.Following surgery, the patient needed to be placed on ecmo.Approximately two hours later the patient died.The surgeon reports that the death was not due to the valves and that the patient was very sick.
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.The original event information indicated that the reported patient death was a result of patient condition (sickness) and was not related ot the device in question.Based on this information and the results of the device history record review it can be determined that the root cause of this event is not device related.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7403820
• Report Number: 3005687633-2018-00135
• Device Sequence Number: 10772141
• Product Code: KRH
• UDI-Device Identifier: 08022057015082
• UDI-Public: (01)08022057015082(240)ICV1333(17)221113
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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: Physician
• Device Expiration Date: 11/13/2022
• Device Model Number: MRCS30
• Device Catalogue Number: ICV1333
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/15/2018
• 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: Death; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 48