Model Number RONYX22522UX |
Device Problems
Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
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Patient Problems
Cardiopulmonary Arrest (1765); Death (1802); Pain (1994); Pericardial Effusion (3271)
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Event Date 07/07/2018 |
Event Type
Death
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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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Event Description
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It was reported that an attempt was made to use a resolute onyx drug eluting stent to treat a lesion in the mid lad with mild tortuosity and calcification and 100% stenosis.No abnormalities were noted in the patient¿s anatomy.The device was removed from packaging with no issues noted.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was predilated.Resistance was encountered, and excessive force was not used.It was reported that stent deformation occurred during positioning and advancement in the artery.When the device was removed from the patient, it was noted that a stent strut was lifted.The lesion was re-predilated using a non-medtronic balloon and two other resolute onyx stents were implanted with no issues noted.Post procedure, the patient complained of pain and an echo was performed.Fluid was found in the patient's heart.Pericardiocentesis was performed and 35cc of fluid removed.The patient coded and passed away on the helicopter pad awaiting transfer.No further patient complications reported for this event.
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Manufacturer Narrative
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Additional information received reported that there was no evidence of a stent thrombosis.It is believed that the patient death is unrelated to the stents, as the patient coded prior to coming to the lab and then coded again after the procedure.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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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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