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

Model Number	AF-826
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Limited information is known on this event to date and the manufacturer is reporting in a conservative manner while in the progress of following up with the site to determine further information.Please note that as no details are known to date of which device remains implanted, device af 826 s/n (b)(4) has been referenced for this report, but this event may also be related to af 832 s/n (b)(4), mfr date on may 24, 2017 expiry date on april 23, 2022.Udi# (b)(4).This will be clarified through supplementary emdr when confirmed by the site.Not yet determined if device available.
Event or Problem Description
On (b)(6) 2017 the manufacturer was notified through patient tracking of 2 patient tracking registration forms received for the same patient for implant of 2 annuloflex mitral annuloplasty rings (af-832 and af-826) on the same day (b)(6) 2017.It is not known to date which device remains implanted.

• 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: 7041656
• Report Number: 3005687633-2017-00115
• Device Sequence Number: 13962428
• Product Code: KRH
• UDI-Device Identifier: 08022057013606
• UDI-Public: (01)08022057013606(240)AF-826(17)210920
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: 09/20/2021
• Device Model Number: AF-826
• Device Catalogue Number: AF-826
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/17/2017
• 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: 51 YR