MAUDE Adverse Event Report: ABBOTT MEDICAL SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Catalog Number	SARP-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The article "valve-in-ring transcatheter mitral valve replacement in a fluoroscopically invisible ring" was reviewed.The article presented a case study of a 84-year-old man who underwent mitral annuloplasty with a 30-mm seguin ring in 2002 developed severe mitral regurgitation (mr).Echocardiography showed left ventricular ejection fraction of 40%, severe mr with an effective regurgitant orifice area of 0.4 cm2, diminutive posterior mitral valve leaflet, and a mitral valve gradient of 17/5 mm hg.He was deemed high risk for repeat surgery and anatomically unfavorable for transcatheter edge-to-edge repair.Heart team consensus was to perform valve-in-ring transcatheter mitral valve replacement.Given the proximity of the left circumflex artery (lcx) to the mitral annulus, during preprocedure computed tomography analysis, its course along the circumference of the seguin ring and deployment angle was determined.The mitral annular area was 553.6 mm2 , and a 29-mm sapien 3 (edwards lifesciences) transcatheter heart valve (thv) was chosen.Anterior mitral leaflet modification was not required given the fact that the neo¿left ventricular outflow tract area was 500 mm.A coronary wire was first positioned in the lcx.After transseptal puncture with the versacross system (boston scientific), optimal thv positioning and deployment were determined using a combination of transesophageal echocardiography, fluoroscopy with the lcx wire as a landmark in proximity to the seguin ring, and an arteriogram and ventriculogram to demarcate the atrioventricular groove there was no residual mr or left ventricular outflow tract obstruction.In conclusion, this case demonstrated that lcx wiring potentially enhances procedural precision.If implantation depth is determined using this technique, it is important to pay attention to the relationship of the lcx and annuloplasty ring using the preprocedural computed tomography scan.Any mismatch must then be taken into consideration in the catheterization laboratory when deploying the thv.[the primary and corresponding author was simon cheung-chi lam md, cardiology division, department of medicine, queen mary hospital, the university of hong kong, 102 pok fu lam road, pok fu lam, hong kong island, hong kong.E-mail: drsimonlam@gmail.Com].
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article titled "valve-in-ring transcatheter mitral valve replacement in a fluoroscopically invisible ring".
Additional Manufacturer Narrative
As reported in a research article, a case study of a 84-year-old man who underwent mitral annuloplasty with a 30-mm seguin ring in 2002 developed severe mitral regurgitation (mr).Echocardiography showed left ventricular ejection fraction of 40%, severe mr with an effective regurgitant orifice area of 0.4 cm2, diminutive posterior mitral valve leaflet, and a mitral valve gradient of 17/5 mm hg.Heart team consensus was to perform valve-in-ring transcatheter mitral valve replacement as the patient was deemed high risk for repeat surgery and anatomically unfavorable for transcatheter edge-to-edge repair.Given the proximity of the left circumflex artery (lcx) to the mitral annulus, during pre-procedure computed tomography analysis, its course along the circumference of the seguin ring and deployment angle was determined and a 29 mm non-abbott transcatheter heart valve was chosen.In conclusion, this case demonstrated that lcx wiring potentially enhances procedural precision.If implantation depth is determined using this technique, it is important to pay attention to the relationship of the lcx and annuloplasty ring using the preprocedural computed tomography scan.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20352159
• Report Number: 2135147-2024-04836
• Device Sequence Number: 7999969
• Product Code: KRH
• UDI-Device Identifier: 05415067044815
• UDI-Public: 05415067044815
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K092310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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 Catalogue Number: SARP-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male