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

Model Number	RSAR-34
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Dyspnea (1816); Headache (1880); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Heart Block (4444)
Date of Event	08/25/2021
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 23 june 2021, a 34mm sjm rigid saddle ring was implanted.On (b)(6) 2021, the patient presented with intermittent short term supraventricular tachycardia and mitral valve prolapse (mvp) and medication was stopped.On (b)(6) 2021, the patient was discharged.On (b)(6) 2021, the patient presented to the emergency room (er) experiencing palpitations and an electrocardiogram (ecg) was performed and noted atrial fibrillation, with a fast ventricular response and secondary repolarization disorder was reported.The patient received 300mg of amiodarone which resolved the arrhythmia and covered to sinus rhythm.This is most likely due to the implant procedure.The patient was reported to be in stable condition and is now home.(b)(4).
Additional Manufacturer Narrative
Correction: b5, d6a.
Event or Problem Description
It was reported on (b)(6) 2021, a 34mm sjm rigid saddle ring was implanted in the mitral position.On (b)(6) 2021, the patient presented with intermittent short term supraventricular tachycardia and mitral valve prolapse (mvp) and medication was stopped.The patient was experiencing dyspnea and palpitations due to the mvp.The patient was admitted to the hospital due to the mvp.On (b)(6) 2021, the patient was discharged.On (b)(6) 2021, the patient presented to the emergency room (er) experiencing palpitations and an electrocardiogram (ecg) was performed and noted atrial fibrillation, with a fast ventricular response and secondary repolarization disorder was reported.The patient received 300mg of amiodarone which resolved the arrhythmia and covered to sinus rhythm.This is most likely due to the implant procedure.The patient was reported to be in stable condition and is now home.On (b)(6) 2021, the patient present to the hospital with a headache and low blood pressure.A tee was performed for rule out pericardial fluid.No pericardial fluid was noted.
Additional Manufacturer Narrative
An event of intermittent short term supraventricular tachycardia and mitral valve prolapse (mvp) was reported.A more comprehensive assessment 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 RIGID SADDLE 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: 12439100
• Report Number: 3007113487-2021-00027
• Device Sequence Number: 20037476
• Product Code: KRH
• UDI-Device Identifier: 05414734009461
• UDI-Public: 05414734009461
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K042734
• 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,Followup
• Report Date (Section B): 10/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2026
• Device Model Number: RSAR-34
• Device Catalogue Number: RSAR-34
• Device Lot Number: 7852568
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 10/26/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/14/2021; 10/27/2021
• 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: 58 YR
• Patient Weight: 58