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Model Number IPN915322 |
Device Problem
Positioning Problem (3009)
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Patient Problems
Abdominal Pain (1685); Cardiac Arrest (1762); Failure of Implant (1924); Tachycardia (2095); Cardiogenic Shock (2262); Diminished Pulse Pressure (2606); Thromboembolism (2654); Unspecified Kidney or Urinary Problem (4503)
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Event Date 12/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that there were three different events on three different patients in the last six months.The report states, "in oc tober 2022 the patient had a ventricular tachycardia (vt) arrest, cardiogenic shock, and was listed for heart transplant.Admitted on 12/4/22 for advanced therapies and vad/transplant evaluation.On (b)(6) 2022, an ultra flex 7f 40 cc iabp placed in the right femoral artery for worsening cardiogenic shock.The patient was heparinized with therapeutic anti-xa and the patient was on 1:1 iabp.Later that day, the patient developed abdominal pain, which was found on cta to be secondary to arterial thrombi in the right hepatic artery and its proximal branches and in segmental branches of the left kidney, with multiple renal infarcts.On 12/31/22, the iabp was discontinued due to thrombotic/embolic complications - iabp-related arterial embolism.He also developed loss of distal pulses in the right lower extremity requiring surgery as below.Heparin induced thrombocytopenia was thought to be unlikely after clinical and laboratory assessment.The patient was anticoagulated with bivalrudin.He had worsening acute kidney injury on chronic kidney injury.Another balloon was not used.On 1/3/23, the patient underwent an embolectomy/thrombectomy of the right leg.On 1/10/23, a biventricular assist device (bivad) was placed.The patient is currently still admitted".
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Event Description
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It was reported that there were three different events on three different patients in the last six months.The report states, "in oc tober 2022 the patient had a ventricular tachycardia (vt) arrest, cardiogenic shock, and was listed for heart transplant.Admitted on (b)(6)22 for advanced therapies and vad/transplant evaluation.On (b)(6)22, an ultra flex 7f 40 cc iabp placed in the right femoral artery for worsening cardiogenic shock.The patient was heparinized with therapeutic anti-xa and the patient was on 1:1 iabp.Later that day, the patient developed abdominal pain, which was found on cta to be secondary to arterial thrombi in the right hepatic artery and its proximal branches and in segmental branches of the left kidney, with multiple renal infarcts.On (b)(6)22, the iabp was discontinued due to thrombotic/embolic complications - iabp-related arterial embolism.He also developed loss of distal pulses in the right lower extremity requiring surgery as below.Heparin induced thrombocytopenia was thought to be unlikely after clinical and laboratory assessment.The patient was anticoagulated with bivalrudin.He had worsening acute kidney injury on chronic kidney injury.Another balloon was not used.On (b)(6)23, the patient underwent an embolectomy/thrombectomy of the right leg.On (b)(6)23, a biventricular assist device (bivad) was placed.The patient is currently still admitted".
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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