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

Model Number	SARP-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Flutter (1730); Bradycardia (1751); Hemorrhage/Blood Loss/Bleeding (1888); Tachycardia (2095)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported on (b)(6) 2021, a 28mm sjm sã©guin semi-rigid annuloplasty ring was implanted.Post procedure, coagulopathy was reported and the patient was given iv medications and patient presented in brady-tachy-arrhythmia and a pacemaker was implanted.On (b)(6) 2021, rhythms disorder was noted and was treated with magnesium and amiodarone.The patient was reported to be in stable condition.(crd_985 - arb pmcf; de4019-157; r622091501, r622092301, r622088301).
Additional Manufacturer Narrative
An event of coagulopathy and brady-tachy-arrhythmia 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 SGUIN 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
• MDR Report Key: 12407685
• Report Number: 3007113487-2021-00025
• Device Sequence Number: 4381730
• Product Code: KRH
• UDI-Device Identifier: 05414734007504
• UDI-Public: 05414734007504
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 06/21/2024
• Device Model Number: SARP-28
• Device Catalogue Number: SARP-28
• Device Lot Number: 7576517
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 75