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Catalog Number UNK DENALI |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Death
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Manufacturer Narrative
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Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
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Event Description
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It was reported through the litigation process that some time post vena cava filter deployment the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
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Manufacturer Narrative
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H10: manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Post-deployment, x-ray of abdomen was performed which revealed there was an inferior vena cava filter in good position.Around, nineteen days later, computed tomography of abdomen and pelvis without contrast was performed which revealed an inferior vena cava filter.Around one year and ten months later, peripheral venogram was performed for acute thrombosis of bilateral lower extremities extending into inferior vena cava and inferior vena cava filter.Venogram showed bilateral popliteal veins with runoff to the mid femoral vein which became occluded with thrombus in the mid segment with no collateral flow or reconstitution above this.An advantage glidewire and a 0.035 quick-cross catheter was wired across the thrombotic occlusion up through the inferior vena cava filter and placed ekosonic endovascular system catheters throughout bilateral femoral veins extending up into the inferior vena cava through the filter.There were no device deficiencies identified within the medical records.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported through the litigation process that some time post vena cava filter deployment the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
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Search Alerts/Recalls
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