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

Model Number RSAR-34

Device Problem Incomplete Coaptation (2507)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Headache (1880); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Heart Block (4444)

Event Date 08/25/2021

Event Type  Injury  

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 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).

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.

Manufacturer Narrative

Correction: b5, d6a.

Event 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.

• Brand Name: SJM RIGID SADDLE RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 12439100
• MDR Text Key: 270302257
• Report Number: 3007113487-2021-00027
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734009461
• UDI-Public: 05414734009461
• Combination Product (y/n): N
• PMA/PMN Number: K042734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 58