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

Model Number	RIGID SADDLE RING
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_985 - arb pmcf, patient site id: eu1671 - 347, r708040801, r708041101.It was reported that on (b)(6) 2022, a 32mm rigid saddle ring was implanted in the mitral valve.Patient had secondary mitral valve disease caused by left atrial enlargement.The surgery also included a tricuspid annuloplasty using a non-abbott device.The patient had secondary tricuspid valve disease caused by left-sided valve disease.There were no intraprocedural adverse events reported.Following procedure, patient had left ventricle ejection fraction (lvef) of 35%.This event led to a prolonged hospitalization.The medication milrinone, an inotropic agent, was administered.On (b)(6) 2022, the patient had an electrocardiogram (ecg) showing an atrioventricular (av) heart block.The patient received an external atrial pacemaker lead.On (b)(6) 2022, a transthoracic echocardiogram (tte) was performed showing a normal lvef.The patient status was stable.
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 information: (b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2022, a 32mm rigid saddle ring was implanted in the mitral valve.Patient had secondary mitral valve disease caused by left atrial enlargement.The surgery also included a tricuspid annuloplasty using a non-abbott device.The patient had secondary tricuspid valve disease caused by left-sided valve disease.There were no intraprocedural adverse events reported.Following procedure, patient had left ventricle ejection fraction (lvef) of 35%.This event led to a prolonged hospitalization.The medication milrinone, an inotropic agent, was administered.On (b)(6)2022, the patient had an electrocardiogram (ecg) showing an atrioventricular (av) heart block.The patient received an external atrial pacemaker lead.On (b)(6) 2022, a transthoracic echocardiogram (tte) was performed showing a normal lvef.The patient status was stable.Subsequent to the previously filed report, additional information was received that the patient's heart block specifically an alternately junctional rhythm, 2:1 heart block, and a 3rd degree atrioventricular (av) heart block.On (b)(6) 2022, the left ventricular systolic function was normal, and the left ventricular diastolic function could not be determined.On (b)(6) 2022, the patient was discharged home without a permanent pacemaker implant.
Additional Manufacturer Narrative
An event of atrioventricular block and low left ventricular ejection fraction was reported.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 indicated the patient's left ventricular ejection fraction returned to normal one week after the implant procedure and that a permanent pacemaker was not needed.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 15365948
• Report Number: 2135147-2022-01018
• Device Sequence Number: 1596445
• Product Code: KRH
• UDI-Device Identifier: 05414734009454
• UDI-Public: 05414734009454
• 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: 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): 11/29/2022

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 Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-32
• Device Lot Number: 8417382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 109 KG