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

Model Number	AF-8
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was notified that an anuloflex ring was implanted and explanted on (b)(6) 2017.Two more devices were attempted during the procedure: a mechanical valve sz 31 (implanted/explanted) and sz 29 (implanted).Patient currently has the mechanical sz 29 implanted.
Additional Manufacturer Narrative
Mfr report # 3005687633-2017-00056 houses the report of the 2nd explanted device mention on the initial report (mechanical mitral valve sz 31).

• Brand Name: ANNULOFLEX MITRAL ANNULOPLASTY RING
• Common Device Name: ANNULOFLEX MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.I.; via crescentino sn; saluggia, vc
• MDR Report Key: 6606403
• Report Number: 3005687633-2017-00055
• Device Sequence Number: 19081313
• Product Code: KRH
• UDI-Device Identifier: 08022057013613
• UDI-Public: (01)08022057013613(240)AF-828(17)211031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

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: No Information
• Device Expiration Date: 10/31/2021
• Device Model Number: AF-8
• Device Catalogue Number: AF-828
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 08/15/2017
• 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: Congenital Anomaly; Required Intervention
• Patient Age: 61 YR