MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. ANNULOFLO SYSTEM, MITRAL; MITRAL ANNULOPLASTY RING

Model Number	AR-7
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Regurgitation (1716); Dyspnea (1816); No Information (3190)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Disposition not presently known.
Event or Problem Description
An annuloflo, size 30, was implanted on (b)(6) 2012.On (b)(6) 2018, the device was explanted and replaced with an annuloflex, size 32.No other information was provided.
Event or Problem Description
A mitral valve repair was performed on (b)(6) 2012.The repair was complicated, with chords to the anterior leaflet, closure of the posterior medial commissure, and implant of a #30 carbomedics annuloflo ring.After a few years, recurrent mitral regurgitation was identified, but the patient was doing well, clinically.The patient became more symptomatic in 2018, and was admitted for heart failure with dyspnea on exertion.Tee performed on (b)(6) 2018 revealed ring dehiscence in the posterior lateral aspect of the ring, and regurgitation from that area.There also appeared to be a possible flail chord, but this was reportedly difficult to confirm.The ejection fraction was normal.Mild tricuspid regurgitation and mild dilation of the right ventricle with decreased rv contractility were present.Reoperation was performed on (b)(6) 2018 and dehiscence of the ring was confirmed.The ring and repair were otherwise intact.The valve was repaired by excision of the ring and edge-to-edge repair.A #32 carbomedics annuloflex ring was then implanted.The patient tolerated the procedure well.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.As the device was not received for analysis, no further investigation can be performed.However, based on the document review performed, no manufacturing deficiencies were identified.Based on the information provided, a size 30 annuloflo ring was explanted and replaced with a size 32 annuloflex ring.This suggests that mis-sizing may have contributed to the event, as ring undersizing is a known contributing factor to ring dehiscence.

• Brand Name: ANNULOFLO SYSTEM, MITRAL
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8117651
• Report Number: 3005687633-2018-00223
• Device Sequence Number: 1692730
• Product Code: KRH
• UDI-Device Identifier: 08022057013682
• UDI-Public: (01)08022057013682(240)AR-730(17)150301
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2019

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: Health Professional
• Device Expiration Date: 01/03/2015
• Device Model Number: AR-7
• Device Catalogue Number: AR-730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 01/17/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/20/2018; 01/18/2019
• 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: 56 YR