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

Model Number	AF-832
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Insufficiency (1963); No Information (3190)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time there is no indication of a device malfunction.The site reported a failed repair with no further details.The root cause cannot be established at this time.If further information is received the case will be reassessed.
Event or Problem Description
On (b)(6) 2019 a patient received an annuloflex af-832 mitral repair ring.The manufacturer was notified that the repair attempt failed and the device was explanted.No other information was provided.
Event or Problem Description
On (b)(6) 2019 a patient received an annuloflex af-832 mitral repair ring.The manufacturer was notified that the repair attempt failed and the device was explanted.No other information was provided.The manufacturer received the following updated information from the site regarding the event on (b)(6) 2020.Preoperative assessment and indications for surgery.83 year old male patient with a history of cad s/p lad pcl/stent, htn, hld, ckd, bph, and hypothyroidism.Patient presented with acute pulmonary edema with sob and orthopnea.He was found to have cute diastolic hf due to severe mr, torn chordae and partial flail of p2.(nyha iii) he was diuresed at osh with improvement in cardiopulm symptoms and transferred to ppmc on (b)(6) 2019.Symptoms developed two to three days prior to admission.Tee performed revealed ef 60-65%, severe mr, flailed mitral leaflevp2.There was moderate leaflet calcification of the area under the flail segment.Cardiac catheterization revealed no obstructive coronary artery disease greater than 50%.The lad stent was widely patent.There was severe calcification in the coronaries.There was severe mr on v-gram with good lv function.At time of operation intraoperative tee confirmed the above.Operation: on valve analysis there was relatively sparse leaflet tissue, with a relatively small anteriorly leaflet.There was a flail area of p2 (fibroelastic deficiency).The flail segment was calcified at its base.The valve was repaired attempted by placing 2 gortex chords to the p2 segment and implanting the annuloflex af-832 mitral repair ring).The patient was weaned from cardiopulmonary bypass without difficulty.Repeat tee showed a central jet at p2 of mild to moderate mitral regurgitation, no sam and no change in lv function.Probable cause was excess calcium on the leaflet.Valve replacement was performed due to patients age.The ring was removed, and the valve was replaced with a # 25 st.Jude mosaic porcine prosthesis (model # e100"25m-00, serial# (b)(6)).The patient was again weaned from cp bypass without difficulty.Repeat tee showed a well functioning prosthesis, no paravalvular leak and no change in lv function.
Additional Manufacturer Narrative
On (b)(6) 2019 a patient received an annuloflex af-832 mitral repair ring.The manufacturer was notified that the repair attempt failed and the device was explanted.No other information was provided.The manufacturer received the following updated information from the site regarding the event on (b)(6) 2020.Preoperative assessment and indications for surgery.83 year old male patient with a history of cad s/p lad pcl/stent, htn, hld, ckd, bph, and hypothyroidism.Patient presented with acute pulmonary edema with sob and orthopnea.He was found to have cute diastolic hf due to severe mr, torn chordae and partial flail of p2.(nyha iii) he was diuresed at osh with improvement in cardiopulm symptoms and transferred to ppmc on (b)(6) 2019.Symptoms developed two to three days prior to admission.Tee performed revealed ef 60-65%, severe mr, flailed mitral leaflevp2.There was moderate leaflet calcification of the area under the flail segment.Cardiac catheterization revealed no obstructive coronary artery disease greater than 50%.The lad stent was widely patent.There was severe calcification in the coronaries.There was severe mr on v-gram with good lv function.At time of operation intraoperative tee confirmed the above.Operation: on valve analysis there was relatively sparse leaflet tissue, with a relatively small anteriorly leaflet.There was a flail area of p2 (fibroelastic deficiency).The flail segment was calcified at its base.The valve was repaired attempted by placing 2 gortex chords to the p2 segment and implanting the annuloflex af-832 mitral repair ring).The patient was weaned from cardiopulmonary bypass without difficulty.Repeat tee showed a central jet at p2 of mild to moderate mitral regurgitation, no sam and no change in lv function.Probable cause was excess calcium on the leaflet.Valve replacement was performed due to patients age.The ring was removed, and the valve was replaced with a # 25 st.Jude mosaic porcine prosthesis (model # e100"25m-00, serial# (b)(6)).The patient was again weaned from cp bypass without difficulty.Repeat tee showed a well functioning prosthesis, no paravalvular leak and no change in lv function.Based on the information received the event was not attributable to any device related malfunctions and the removal of the annuloflex ring was a result of pre-existing patient factors which required a procedural change from a repair to a full valve replacement.To ensure the device met all standards and requirements 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.The root cause of the reported event is thus deemed to be, cause cannot be traced to device : adverse event related to patient condition fields changed: b4, b5, g4, g7, h2, h6.

• 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
• MDR Report Key: 9413728
• Report Number: 3005687633-2019-00266
• Device Sequence Number: 16885703
• Product Code: KRH
• UDI-Device Identifier: 08022057013637
• UDI-Public: (01)08022057013637(240)AF-832(17)231231
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: 12/31/2023
• Device Model Number: AF-832
• Device Catalogue Number: AF-832
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 03/18/2020
• 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: 83 YR