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

Model Number	AR-732
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	05/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to limited information, this event is being reported in a conservative manner.Device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2017, the manufacturer was notified by patient registration form (prf) that an annuloflex mitral annuloplasty ring sz 32 was implanted and explanted on (b)(6) 2017.During the procedure the physician implanted the ring, tested the native mitral valve and then decided to remove the ring.The physician performed a surgical repair and no ring or heart valve prosthesis was implanted.The procedure was extended but the increase in x-clamp time was not reported to the manufacturer.The ring was disposed by the hospital after explant.No patient complications were notified to the manufacturer.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device was performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Given that the device was not returned, no further investigation is possible at this time; however, from the customer narrative provided, the ring repair was insufficient, and the physician opted for surgical repair of the valve instead.As such, this event is attributable to the patient's condition, which precluded adequate repair via annuloplasty ring.The event is therefore considered to be not-device-related.

• Brand Name: ANNULOFLEX MITRAL ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.I.; via crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 6640378
• Report Number: 3005687633-2017-00063
• Device Sequence Number: 1082769
• Product Code: KRH
• UDI-Device Identifier: 08022057013699
• UDI-Public: (01)08022057013699(240)AR-732(17)200913
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/18/2017

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: 09/13/2020
• Device Model Number: AR-732
• Device Catalogue Number: AR-732
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 10/18/2017
• 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: 82 YR