Model Number 24009 |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
Aortic Dissection (2491)
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Event Date 11/16/2015 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic received information indicating the patient's aorta was dissected while using an aortic root cannula.The customer repaired the damaged aorta and there were no additional adverse patient effects.The product has not been returned to medtronic, therefore the evaluation is still in progress.A supplemental report will be filed once the investigation is completed.(b)(4).
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Event Description
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Medtronic received information indicating that during a procedure, the customer reported the pressure line of this aortic root cannula seemed to be occluded.The customer replaced the cannula with another, creating a second hole in the patient's aorta.After the cannula had been replaced, it was determined that the patient's aorta had been dissected.The customer repaired the damaged aorta and there were no additional adverse patient effects.
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Manufacturer Narrative
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Conclusion: medtronic cannot confirm or deny the complaint of an occluded pressure line of the aortic root cannula as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.A review of complaints received from november 2014 through december 2015 for this part number showed no trends related to this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.(b)(4).
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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