MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L ANNULOFLEX MITRAL ANNULOPLASTY RING

Model Number	AF-836
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported in a conservative manner based on the unknown additional x clamp for the failure to implant.No further information will be provided by the physician to the manufacturer as no product issue was determined by the physician.Device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2017 the manufacturer was notified through patient tracking of a failure to implant annuloflex mitral annuloplasty ring af-836 on (b)(6) 2017.On follow up with the site further information was received that during the procedure the physician noted that the mitral valve repair did not take and that a mitral valve replacement was required.A mitral tissue valve was then implanted (make/size unknown).

• Brand Name: ANNULOFLEX MITRAL 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: 6978447
• Report Number: 3005687633-2017-00106
• Device Sequence Number: 1130934
• Product Code: KRH
• UDI-Device Identifier: 08022057013651
• UDI-Public: (01)08022057013651(240)AF-836(17)210905
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K023185
• 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
• Report Date (Section B): 10/25/2017

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: 09/05/2021
• Device Model Number: AF-836
• Device Catalogue Number: AF-836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/25/2017
• 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: 63 YR