MAUDE Adverse Event Report: ABBOTT MEDICAL SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Catalog Number	RSAR-26
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Fever (1858); Pain (1994); Pleural Effusion (2010); Pneumonia (2011); Pericarditis (4448)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Crd_985 - arb pmcf, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 26mm sjm rigid saddle ring was chosen for mitral valve repair.It was also reported the patient underwent concomitant commissurotomy to treat mitral stenosis and also left atrial appendage closure.It was reported prior to discharge on (b)(6) 2022, pleural effusion was detected during follow-up chest x-ray and a decision was made to perform a pleural puncture for pleural effusion drainage.A follow-up chest x-ray on (b)(6) 2022 reported no pathology.It was then reported on (b)(6) 2022, the patient was admitted for fever, chest pain, pneumonia, and was treated with antibiotics.The patient was discharged from the hospital on (b)(6) 2022.The patient was rehospitalized on (b)(6) 2022 due to worsening pleural effusion.A repeat chest x-ray on (b)(6) 2022 did not confirm pleural effusion.A computed tomography (ct) scan on (b)(6) 2022 noted minimal pleural effusion.The patient was discharged (b)(6) 2022 following no treatment.It was then reported on (b)(6) 2022, the patient presented again with slight pain and chest discomfort that was worsened with breathing deeply.It was also noted the patient had slight increase in inflammatory markers with sub-fever symptoms.Electrocardiogram (ecg) on (b)(6) 2022 noted diffuse st-elevation and pericarditis was suspected.Transthoracic echocardiography (tte) on (b)(6) 2022 noted 52% ejection fraction and no issues with the repaired mitral valve.Transesophageal echocardiography (tee) confirmed normal function of the mitral valve and did not report any endocarditis.The patient was discharged on (b)(6) 2022 after treatment of post-operative pericarditis with prescribed medication (ibuprofen 600mg x3, omeprazole 40mg x1, and colchicine 0,5mg x1) for home use for 6 months.The current patient status was reported stable.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of chest pain, fever, hospitalization, pericarditis, pneumonia, pleural effusion was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the available information, the cause of the reported chest pain is likely related to the reported pleural effusion; however, the cause of pleural effusion could not be conclusively determined.The cause of the reported fever, pericarditis, and pneumonia could not be conclusively determined.The reported hospitalization and unexpected medical intervention were result of case-specific circumstances as the patient was admitted for pleural drainage and medication administration.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: SJM RIGID SADDLE 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: 20663380
• Report Number: 2135147-2024-05693
• Device Sequence Number: 8502509
• Product Code: KRH
• UDI-Device Identifier: 05415067044655
• UDI-Public: (01)05415067044655(17)250514(10)7518547
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: K042734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 05/14/2025
• Device Catalogue Number: RSAR-26
• Device Lot Number: 7518547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2020
• 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; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 60 KG