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Model Number RIGID SADDLE RING |
Device Problem
Material Separation (1562)
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Patient Problems
Anemia (1706); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Heart Block (4444)
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Event Date 01/20/2023 |
Event Type
Injury
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Event Description
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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.
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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 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.
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Event Description
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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.
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Search Alerts/Recalls
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