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

Model Number	AF-836
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer was notified of this event via the companies patient tracking registry.At this time there is no indication of a device malfunction, insufficiency, patient adverse effect, or possible root cause of the event.Thus the root cause is cause cannot be established.The manufacturer is following up for further information and will update the competent authority if any further information is received.
Event or Problem Description
On (b)(6) 2019 a patient was intended to receive a annuloflex af-836.The manufacturer was notified via the patient tracking system that the device was explanted the same day it was implanted.No further information was received.
Additional Manufacturer Narrative
The manufacturer received additional information.The following updated summary has been included in section b5: on (b)(6) 2019 a patient was intended to receive a annuloflex af-836.The mitral valve was approached through a transeptal incision.The valve had severe bileaflet prolapse, but the significant prolapsing segment was the p3 segment.Initially site did a commissuroplasty from a3 to p3 using 4-0 prolene suture in a running fashion.11 posterior annular sutures placed and downsized the annulus to a 36 posterior ring.However, it was clear that at this point, the ring had deformed the annulus due to it's very large size.Consequently, the site removed the ring.At this point, there was excellent competence of the valve with no further prolapse or leaking.Total cross clamp and bypass time were 80 and 90 minutes respectively.The patient tolerated the procedure well and he went to the intensive care unit in stable condition.Based on the information received regarding the intra-operative failure to implant the root cause of the reported event was attributable to an intra-operative dysfunction/difficulty - cause traced to user : unintended use error caused or contributed to event - mis-sizing fields changed: b4, b5, g4, g7, h2, h6.
Event or Problem Description
On (b)(6) 2019 a patient was intended to receive a annuloflex af-836.The mitral valve was approached through a transeptal incision.The valve had severe bileaflet prolapse, but the significant prolapsing segment was the p3 segment.Initially site did a commissuroplasty from a3 to p3 using 4-0 prolene suture in a running fashion.11 posterior annular sutures placed and downsized the annulus to a 36 posterior ring.However, it was clear that at this point, the ring had deformed the annulus due to it's very large size.Consequently, the site removed the ring.At this point, there was excellent competence of the valve with no further prolapse or leaking.Total cross clamp and bypass time were 80 and 90 minutes respectively.The patient tolerated the procedure well and he went to the intensive care unit in stable condition.

• 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: 9433623
• Report Number: 3005687633-2019-00267
• Device Sequence Number: 448273
• Product Code: KRH
• UDI-Device Identifier: 08022057013651
• UDI-Public: (01)08022057013651(240)AF-836(17)240204
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 03/26/2020

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: 02/04/2024
• Device Model Number: AF-836
• Device Catalogue Number: AF-836
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 03/26/2020
• 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: 57 YR