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

Model Number	RIGID SADDLE RING
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888); Pleural Effusion (2010); Heart Block (4444)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical study patient id: (b)(6).Eu1671 - 810 (r734972601, r734969801, r734974401, r734977801, r735456601, r735573301, r735570501, r735572601, r735571401, r737106901).It was reported that on (b)(6) 2023 a 30mm rigid saddle ring was selected for implant.During the procedure, while the device was being sutured in, the holder became dislodged.The ring was able to be successfully implanted in the patient.Post procedure the patient had hemodynamic instability, distributive shock due to drain leakage (1700 ml) requiring milrinone and noradrenalin.The patient received fresh frozen plasma, platelets, and packed red blood cells.The patient had cardiogenic shock due to right ventricular failure.On (b)(6) 2023, first degree atrioventricular (av) block was reported; no treatment was provided.On (b)(6) 2023, anemia with hemoglobin decreased from 5.5.To 4.4 mmol/l was observed and 1 unit of pack red blood cells was transfused.On (b)(6) 2023, the patient had pleural fluid 4-5 cm requiring diuretics.On (b)(6) 2023, reoperation was performed and thorax drains were placed to drain pleural fluid.Bleeding and clots in the pericardium causing cardiogenic shock was observed.The patient was subsequently sent back to the operative room to stop the bleeding and remove the clots.The patient remained in need of filling and vasopressin.In addition, the patient received albumin due right ventricular failure.The patient was reported to be stable condition.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of atrioventricular (av) block, pleural fluid, distributive shock, hemodynamic instability, cardiogenic shock, chest pain, atrial fibrillation, anemia was reported.A returned device assessment could not be performed as the device remains implanted and 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 specifications.There was no allegation made against the device.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: on (b)(6) 2023, the patient went to the emergency room in referring hospital because of chest pain after mild emotional stress.Troponin value: 76.85 ng/l, a few hours later 62.3 ng/l electrocardiogram showed atrial fibrillation (baseline condition) because of decreased trop-t, patient was discharged home.The patient was reported to be stable condition.

• 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: 16386676
• Report Number: 2135147-2023-00543
• Device Sequence Number: 5138250
• 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: 2023
• 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): 05/09/2023

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 Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-30
• Device Lot Number: 8765539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 04/23/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 67 KG