MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number	SARP-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Coagulation Disorder (1779)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported on (b)(6) 2021, a 30mm sjm sã©guin semi-rigid annuloplasty ring was implanted.Post procedure, worsening afibrinogenemia was noted.The physician noted that as soon as a patient shows an abnormal valve, the coagulation is optimized.The event was reported based of the clinical study protocol.There is no baseline valve for this patient to confirm if there is really a deterioration in health.The patient was administrated medication.The patient was reported to be in stable condition and since has been discharged.(crd_985 - arb pmcf; (b)(4)).
Additional Manufacturer Narrative
Correction: upon review, the sjm sã©guin semi-rigid annuloplasty ring should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.
Event or Problem Description
Subsequent to the initially filed information, the following information was received on (b)(6) 2021: it was reported that the afibrinogenemia diagnosis in this event was used to document temporary changes in fibrinogen levels in the blood.Therefore the information reported initially remains a reportable event.
Additional Manufacturer Narrative
An event of worsening afibrinogenemia was reported.A more comprehensive assessment could not be performed as the device remains implanted 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): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12442950
• Report Number: 3007113487-2021-00033
• Device Sequence Number: 20037480
• 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
• Serviced by Third Party (Y/N): Unknown
• 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): 12/21/2021

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: 09/11/2024
• Device Model Number: SARP-30
• Device Catalogue Number: SARP-30
• Device Lot Number: 7664737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/12/2021; 11/23/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 09/14/2021; 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2020
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 82 KG