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Model Number HERO 1001 |
Device Problem
Difficult To Position (1467)
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Patient Problems
Cardiac Arrest (1762); Death (1802)
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Event Date 10/23/2014 |
Event Type
Death
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Event Description
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Dr.(b)(6) had a very challenging patient with limited access options.(b)(6) placed the wire the day before surgery.Dr.(b)(6) implanted the hero graft in the patient's groin, and he felt like the case went very well.The case finished around 11:20 am.At approximately 1:20 pm, cryolife was told the patient had passed away.Dr.(b)(6) said that the patient went into cardiac arrest post-op, and he does not think that the hero graft was related or associated with the cause of death.As it is unknown if either the hero 1001 or hero 1002 component contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1001 component.
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Event Description
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Dr.(b)(6) had a very challenging patient with limited access options.Ir placed the wire the day before surgery.Dr.(b)(6) implanted the hero graft in the patient's groin, and he felt like the case went very well.The case finished around 11:20 am.At approximately 1:20 pm, cryolife was told the patient had passed away.Dr.(b)(6) said that the patient went into cardiac arrest post-op, and he does not think that the hero graft was related or associated with the cause of death.As it is unknown if either the hero 1001 or hero 1002 component contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1001 component.
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Manufacturer Narrative
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This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
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Manufacturer Narrative
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The surgeon had a very challenging patient with limited access options.Ir placed the wire the day before surgery.The surgeon implanted the hero graft in the patient's groin, and he felt like the case went very well.The case finished around 11:20 am.At approximately 1:20 pm, cryolife was told the patient had passed away.The surgeon said that the patient went into cardiac arrest post-op, and he does not think that the hero graft was related or associated with the cause of death.As it is unknown if either the hero 1001 or hero 1002 component contributed to the reported event, out of caution, it was decided to investigate both.This medwatch is for hero 1001 component.Patient medical records were provided and reviewed.According to the available information the surgeon implanted the hero graft in the patient's groin without complication.Approximately two hours after the surgery was completed the rep was informed that the patient had passed away.During a follow-up phone with the surgeon he stated he did "not think the hero graft was related or associated with cause of death." additional information was sought to further clarify the circumstances and determine if hero graft was potentially associated with the unfortunate outcome.Review of the operative report described a patient to be a (b)(6) male with numerous medical problems including end-stage renal disease, congestive heart failure, and hypertension.These conditions may predispose such a patient to a sudden cardiac event.There were no complications or issues noted or described related to implanted product.There is no alleged deficiency of the hero graft or assertion that the clinical events were related to the product.Therefore, no complaint investigation is warranted and the complaint will be voided.
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Search Alerts/Recalls
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