MAUDE Adverse Event Report: ABBOTT MEDICAL SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Model Number	RIGID SADDLE RING
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Codes	Anemia (1706); Arrhythmia (1721); Atrial Fibrillation (1729); Dyspnea (1816); Nausea (1970); Tachycardia (2095); Vomiting (2144); Pericardial Effusion (3271); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/19/2021
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 study patient id: (b)(6).It was reported that on (b)(6) 2021, a 30mm rigid saddle ring was chosen for procedure.An abbott ring sizer set was used during the procedure.The mitral valve repair included a bilateral leaflet repair as well as a chordal replacement with artificial chordae or suture.There were no intraprocedural adverse events noted.Post procedure, a pericardial effusion was discovered, and a drainage of the pericardium was then performed in the operating room.The patient was also diagnosed with sick sinus syndrome (sss), and a permanent dual-chamber pacemaker was implanted.
Event or Problem Description
Clinical study patient id: (b)(6).It was reported that on (b)(6) 2021, a 30mm rigid saddle ring was chosen for procedure.An abbott ring sizer set was used during the procedure.The mitral valve repair included a bilateral leaflet repair as well as a chordal replacement with artificial chordae or suture.There were no intraprocedural adverse events noted.Post procedure, a pericardial effusion was discovered, and a drainage of the pericardium was then performed in the operating room.The patient was also diagnosed with sick sinus syndrome (sss), and a permanent dual-chamber pacemaker was implanted.Subsequent to the previously filed report, additional information was received that on (b)(6) 2021 after the 30mm rigid saddle ring was implanted, post procedure but prior to discharge from hospital, an echocardiogram was performed which revealed lower wall ischemia on (b)(6) 2021.A coronary angiogram was performed, and no ischemia was visualized.On (b)(6) 2021, the patient experienced nausea, vomiting, and new onset atrial fibrillation.On 4 august 2021, a pericardial effusion was discovered, which was treated with a pericardial drainage.The pericardial effusion did not lead to cardiac tamponade.There was no reported cause of the pericardial effusion.On 4 august 2021, the patient also experienced anemia, and patient was transfused 2 units of red packed blood cells.On (b)(6) 2021, the patient experienced atrial fibrillation with ventricular tachycardia.On (b)(6) 2021, the patient complained of dyspnea on exertion, and a permanent pacemaker was implanted.The patient was later diagnosed with mitral valve plasty failure with severe mitral valve insufficiency.On (b)(6) 2022, the patient had a mitral valve replacement.The 30mm rigid saddle ring was explanted due to mitral regurgitation.A bioprosthetic valve was implanted.A tricuspid valve repair was also performed during surgery.
Additional Manufacturer Narrative
An event of pericardial effusion and sick sinus syndrome after implant of a rigid saddle ring was reported.Also reported was that one year after the ring was implanted the ring was explanted and replaced with a prosthetic valve due to regurgitation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field showed no indication of device malfunction.It was indicated that the pericardial effusion and the sick sinus syndrome were due to the implant procedureh6 health effect - clinical code: 1721 code removed.Codes 1729, 2095, 1702, 4451, 1970, 2144, and 1816 were added.H6 health effect - impact code: 4607 code and 4641 code added.H6 medical device problem code: 2993 code removed.

• Brand Name: SJM RIGID SADDLE 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: 14517033
• Report Number: 2135147-2022-00319
• Device Sequence Number: 6531248
• Product Code: KRH
• UDI-Device Identifier: 05414734009447
• UDI-Public: 05414734009447
• 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
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 03/28/2026
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-30
• Device Lot Number: 7907090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 81 KG