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

Model Number	MRCS28
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	05/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to limited information, this event is being reported in a conservative manner.Not yet determined if device available.
Event or Problem Description
On 30 may 2017 the manufacturer received notification through patient tracking of a memo 3d rechord semirigid annuloplasty ring that was implanted/explanted on (b)(6) 2017.
Additional Manufacturer Narrative
As per physician medical judgment of failure to implant mitral ring due to the patient requiring a mitral valve replacement , this event was not device related and no investigation will be performed.The device is not available for return.Device not returned to manufacturer.
Event or Problem Description
The manufacturer was notified through patient tracking of a memo 3d rechord, (b)(4) that was implanted/explanted on (b)(6) 2017.On follow up with the physician it was determined that failure to implant the mitral ring was due to patient anatomy.As per physician medial judgment the patient required a full mitral valve replacement and a mitral ring repair was not possible.The memo 3d rechord was removed and a 27mm bioprosthesis (model/brand unknown) was used for the mitral replacement.The amount of added xclamp time for the mitral valve replacement is not known.Patient left the or in satisfactory condition but still in critical condition for postoperative care (as of (b)(6) 2017).The device is not available for analysis.

• 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: 6676029
• Report Number: 3005687633-2017-00067
• Device Sequence Number: 19325604
• Product Code: KRH
• UDI-Device Identifier: 08022057013118
• UDI-Public: (01)08022057013118(240)ICV0968(17)210608
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,Followup
• Report Date (Section B): 12/12/2017

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: 06/08/2021
• Device Model Number: MRCS28
• Device Catalogue Number: ICV0968
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 12/12/2017
• 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: 70 YR