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

Model Number	AF-828
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/25/2017
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 (b)(6) the manufacturer received notification through patient tracking of an annuloflex mitral annuloplasty ring that was implanted and explanted on (b)(6) 2017.
Additional Manufacturer Narrative
The manufacturer received information that the attempted annuloplasty ring repair failed due to lack of tissue.Based on the information provided, the event is attributable to the patient's physiology and is therefore not device-related.As such, no further investigation is required.Device not available for return.

• 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: 6676004
• Report Number: 3005687633-2017-00066
• Device Sequence Number: 13967945
• Product Code: KRH
• UDI-Device Identifier: 08022057013613
• UDI-Public: (01)08022057013613(240)AF-828(17)210117
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/14/2017

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: 01/17/2021
• Device Model Number: AF-828
• Device Catalogue Number: AF-828
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 12/14/2017
• 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: 39 YR