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

Catalog Number	RSAR-32
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) - arb pmcf, patient site id: (b)(6).It was reported that on 08 december 2022, a 32mm rigid saddle ring was implanted for mitral valve repair.It was then reported on 07 december 2023, the patient was admitted for worsening of general condition.The patient was diagnosed mitral regurgitation due to annuloplasty device dehiscence.It was then reported on an unknown date, a decision was made to surgically remove the 32mm rigid saddle ring and replaced with an unknown device.The patient status was reported as discharged.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of mitral regurgitation due to annuloplasty device dehiscence and explant was reported.A more comprehensive assessment, including histopathological examination of the device could not be performed as the device 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 information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Additional Manufacturer Narrative
An event of mitral regurgitation due to annuloplasty device dehiscence and explant was reported.A more comprehensive assessment, including histopathological examination of the device could not be performed as the device 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 information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
(b)(4).It was reported that on (b)(6) 2022, a 32mm rigid saddle ring was implanted for mitral valve repair.It was then reported on (b)(6) 2022, the patient was admitted for heart failure.A transthoracic echocardiography on (b)(6) 2022 confirmed severe mitral regurgitation due to annuloplasty device dehiscence.A transesophageal echocardiography on (b)(6) 2022 also confirmed severe mitral regurgitation.A decision was made to surgically remove the 32mm rigid saddle ring on (b)(6) 2022 and replaced with an unknown device.The patient status was reported as discharged on (b)(6) 2023.

• 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: 19288116
• Report Number: 2135147-2024-02109
• Device Sequence Number: 12597427
• Product Code: KRH
• UDI-Device Identifier: 05415067044716
• UDI-Public: (01)05415067044716(17)270515(10)8476886
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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,Followup
• Report Date (Section B): 10/14/2024

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: RSAR-32
• Device Lot Number: 8476886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 10/02/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 05/30/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 90 KG