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

Model Number	SMD30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Limited information is known to date on this event, the manufacturer is reporting in a conservative manner.Not yet determined if device available.
Event or Problem Description
The manufacturer received notification from patient tracking on (b)(6) 2017 of the following: on (b)(6) a memo 3d semirigid annuloplasty ring (size 30, sn# (b)(4)) was implanted/explanted and a carbomedics standard prosthetic heart valve, mitral (m7-027 sn# (b)(4)) was then implanted same day.
Additional Manufacturer Narrative
The complete manufacturing and material records for the memo 3d semirigid annuloplasty ring, model smd30, s/n (b)(4), were retrieved and reviewed by quality control at (b)(4).The results confirmed that this device satisfied all material, visual, and performance standards required for a (model smd30) memo 3d semirigid annuloplasty ring at the time of manufacture and release.No further information will be provided on this event to the manufacturer.Based on limited information received the root cause cannot yet be determined at this time.Based on clinical experience for failure to implant a mitral ring with remedial action of performing a mitral valve replacement, the failure to implant may be attributed to patient condition not suitable for a mitral repair.The device is not available for return or analysis, no further investigation is possible.Not available for return.

• 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: 6850543
• Report Number: 3005687633-2017-00092
• Device Sequence Number: 11143698
• Product Code: KRH
• UDI-Device Identifier: 08022057013125
• UDI-Public: (01)08022057013125(240)ICV0969(17)210823
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/07/2017

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: 08/23/2021
• Device Model Number: SMD30
• Device Catalogue Number: ICV0969
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 12/07/2017
• 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: 55 YR