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Model Number RIGID SADDLE RING |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pneumothorax (2012); Pulmonary Edema (2020); Renal Failure (2041)
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Event Date 02/08/2023 |
Event Type
Death
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Event Description
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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.
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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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.
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Event Description
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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.
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Search Alerts/Recalls
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