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

Model Number	SARP-30
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Anemia (1706); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	10/05/2021
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 information: crd_985 - arb pmcf, patient site id: (b)(6) - 161 (b)(4).It was reported that on (b)(6) 2021, a patient had a 30mm seguin semi-rigid saddle ring implanted.On (b)(6) 2021, the patient was reported to have reduced hemoglobin levels and anemia.No treatment was provided.On (b)(6) 2021, it was reported that the patient had worsening mitral valve regurgitation, discovered by transthoracic echocardiogram.On (b)(6) 2021, the patient was hospitalized for worsening anemia, and was administered a blood transfusion.On (b)(6) 2021, it was reported that the 20mm seguin semi-rigid saddle ring was explanted and an unknown valve was implanted.On (b)(6) 2021, the patient was diagnosed with coagulopathy.The coagulopathy was resolved the same day with the administration of ppsb.Regurgitation was declared resolved (b)(6) 2021.It is suspected but not finally confirmed that mechanical hemolysis after mitral valve reconstruction caused the patient anemia.No additional information was provided.
Additional Manufacturer Narrative
An event of worsening mitral valve regurgitation, reduced hemoglobin levels and anemia requiring a blood transfusion an coagulopathy were reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.

• 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: 15739523
• Report Number: 2135147-2022-01953
• Device Sequence Number: 15003392
• Product Code: KRH
• UDI-Device Identifier: 05414734007511
• UDI-Public: 05414734007511
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K092310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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 Expiration Date: 02/07/2025
• Device Model Number: SARP-30
• Device Catalogue Number: SARP-30
• Device Lot Number: 7837665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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; Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Race: White