CARDIACASSIST INC. PROTEK DUO VENO-VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Type
Injury
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Event Description
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Through literature review livanova became aware of a (b)(6)-year old male patient who underwent orthotopic heart transplantation (oht) with removal of a dual-chamber implantable cardioverter-defibrillator (icd).The protekduo was inserted 2 days post-oht for high cvp and rv dysfunction.Approximately 30 hours later, the patient had symptoms of svc (superior vena cava) syndrome marked swelling of the head and upper extremities and a cvp of 45 mm hg.The protekduo was removed and converted to a central surgical rvad.The patient survived to hospital discharge.The authors concluded that patients with signs of svc syndrome, including facial and chest edema, dyspnea and cough, and non-pulsatile distended neck veins, experienced improvement following either device explantation or removal of the accompanying central venous catheter within the left internal jugular and subclavian venous system.The authors hypothesize that consideration needs to be given to multiple etiologies for svc syndrome and appropriate rv support and early recognition of svc syndrome are needed for preventing venous obstruction.
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Manufacturer Narrative
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Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Cardiacassist inc.Manufactures the protekduo cannula.The incident occurred in (b)(6).A medical assessment of the case was conducted.The reported syndrome is not related to any specific product malfunction and is related to the use of cannula.In addition, this type of event depends on cannula size selected for patient vessel conformation.The syndrome can be solved only by additional medical intervention or by removal of the obstruction.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Cardiacassist inc.Manufactures the protekduo cannula.The incident occurred in (b)(6).A medical assessment of the case was conducted.The reported syndrome is not related to any specific product malfunction and is related to the use of cannula.In addition, this type of event depends on cannula size selected for patient vessel conformation.The syndrome can be solved only by additional medical intervention or by removal of the obstruction.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Through literature review livanova became aware of a (b)(6) year old male patient who underwent orthotopic heart transplantation (oht) with removal of a dual-chamber implantable cardioverter-defibrillator (icd).The protekduo was inserted 2 days post-oht for high cvp and rv dysfunction.Approximately 30 hours later, the patient had symptoms of svc (superior vena cava) syndrome marked swelling of the head and upper extremities and a cvp of 45 mm hg.The protekduo was removed and converted to a central surgical rvad.The patient survived to hospital discharge.The authors concluded that patients with signs of svc syndrome, including facial and chest edema, dyspnea and cough, and non-pulsatile distended neck veins, experienced improvement following either device explantation or removal of the accompanying central venous catheter within the left internal jugular and subclavian venous system.The authors hypothesize that consideration needs to be given to multiple etiologies for svc syndrome and appropriate rv support and early recognition of svc syndrome are needed for preventing venous obstruction.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: as stated in the initial report the reported event is not related to any cannula malfunction.Svc syndrome can be multi-factorial and is an inherent risk of the procedure related to the use of a cannula.
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Search Alerts/Recalls
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