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	Pneumothorax (2012); Pulmonary Edema (2020); Renal Failure (2041)
Date of Event	02/08/2023
Type of Reportable Event	Death
Event or Problem Description
Clinical information : (b)(4).Due to the proximity to the implant procedure this event is being conservatively reported.It was reported that on (b)(6) 2023, a 32mm rigid saddle ring was selected for an implant.It was noted that the patient's procedure was completed successfully.Preoperatively, the patient had pneumococcal pneumonia and developed pulmonary edema.The patient required extensive adhesiolysis and stacking of the hole in the lung.The patient was admitted to intensive care postoperatively.Shortly after, obstructive shock and respiratory failure occurred, the patient was diagnosed with a tension pneumothorax due to hole in lung with adhesion after pneumonia in 2020.The patient required emergency re-thoracotomy because of becoming hemodynamically unstable due to right ventricle failure.The patient ended up in cardiogenic shock due to right ventricular failure and respiratory failure due to pulmonary edema.In addition, the patient had acute renal insufficiency and a thrombus in the left heart ear, for which dalteparin was administered in therapeutic doses.There are no thoughts documented on the cause of the thrombus.On (b)(6) 2023, it was reported that the patient passed away due to procedure complication.
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 pneumococcal pneumonia, obstructive shock, acute renal insufficiency, thrombus in the left heart ear requiring treatment, tension pneumothorax due to hole in lung, right ventricle failure causing cardiogenic shock and respiratory failure due to pulmonary edema and patient death due to procedure complication was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.Based on the information received, the root cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.
Event or Problem Description
Clinical information : (b)(4).Due to the proximity to the implant procedure this event is being conservatively reported.It was reported that on (b)(6) 2023, a 32mm rigid saddle ring was selected for implant.It was noted that the patient's procedure was completed successfully.Preoperatively, the patient had pneumococcal pneumonia and developed pulmonary edema.The patient required extensive adhesiolysis and stacking of the hole in the lung.The patient was admitted to intensive care postoperatively.Shortly after, obstructive shock and respiratory failure occurred, the patient was diagnosed with a tension pneumothorax due to hole in lung with adhesion after pneumonia in 2020.The patient required emergency re-thoracotomy because of becoming hemodynamically unstable due to right ventricle failure.The patient ended up in cardiogenic shock due to right ventricular failure and respiratory failure due to pulmonary edema.In addition, the patient had acute renal insufficiency and a thrombus in the left heart ear, for which dalteparin was administered in therapeutic doses.There are no thoughts documented on the cause of the thrombus.On (b)(6) 2023, it was reported that the patient passed away due to procedure complication.

• 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: 16504611
• Report Number: 2135147-2023-01066
• Device Sequence Number: 3301879
• 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: 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): 04/11/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-32
• Device Lot Number: 8811369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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: Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 78 KG