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

Model Number	SARP-30
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Endocarditis (1834); Fever (1858)
Date of Event	11/02/2022
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
Clinical study patient id: (b)(6), (b)(6).(b)(6).It was reported that on (b)(6) 2022, a 30mm seguin annuloplasty ring was successfully implanted.On (b)(6) 2022, in the evening, the patient developed septic fever up to 40 degrees celsius.Echocardiogram same day showed no problems with valve.On (b)(6), no infection on the implant site but a positive blood culture was noted.Echocardiogram on (b)(6) 2022 showed vegetations on saddle ring and early postoperative endocarditis was diagnosed.The patient was put on antibiotic therapy.On (b)(6) 2022, device was explanted and a non-abbot device implanted due to mitral valve endocarditis.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of septic fever, vegetations on saddle ring, and postoperative endocarditis was reported.A more comprehensive assessment, including histopathological examination of the valve tissue 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.

• 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): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15886668
• Report Number: 2135147-2022-02270
• Device Sequence Number: 14776945
• Product Code: KRH
• UDI-Device Identifier: 05414734007511
• UDI-Public: 05414734007511
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: K092310
• 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
• Report Date (Section B): 02/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SARP-30
• Device Catalogue Number: SARP-30
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White