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Model Number ONYXNG27522X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Anemia (1706); Hematoma (1884); Thrombosis/Thrombus (4440); Insufficient Information (4580)
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Event Date 03/26/2024 |
Event Type
Injury
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Event Description
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An attempt was made to use one onyx frontier coronary drug-eluting stent to treat a non-tortuous, non-calcified lesion in the mid left anterior descending (lad) artery.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was not encountered.Excessive force was not used during delivery.It was reported that a clinical adverse event occurred.It was detailed that the patient suffered an acute stent thrombosis 0-24 hours post stent implantation.The patient presented to hospital with chest pain two days prior to the event and had a history of radiating pain to left shoulder associated with palpitation and breathlessness.The patient was diagnosed with acute coronary syndrome (acs) and given loading dose tenecteplase injection.An electrocardiogram (ecg) showed st elevation, no echocardiographic regional wall motion abnormalities (rwma), adequate left ventricle (lv) function, mild pericardial effusion and troponin i was >25000pg/ml.The patient underwent a coronary artery angiography (cag) which revealed lad d2 bifurcation disease.The patient then underwent a percutaneous coronary intervention (pci) in the lad d2 bifurcation.The patient tolerated the procedure well and the post procedure period was uneventful.A rheumatologist and general physician were consulted regarding the patient¿s known systemic lupus erythematosus (sle) and anemia.One unit of packed red blood cells (prbcs) was transfused without any transfusion reactions.Hemoglobin (hb) was monitored.The patient had lower abdominal pain for which a contrast-enhanced computed tomography (cect) was done.A large pelvic extra-peritoneal hematoma on the right-side causing mass effect on the urinary bladder and a large sub-serosal fibroid of the uterus was seen.One unit of prbc and one unit of whole blood were transfused without reaction.The patient was given iv antibiotics, anticoagulants, antiplatelet, statin, beta-blocker, antianginal, steroid, ppi and other supportive measures.The patient became clinically better and was discharged.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Additional information: the stent was fully expanded and no issues were noted during stent deployment.The thrombus occurred immediately post procedure in the lad distal stent after the wire was taken out.The patient was on dapt when this thrombotic event occurred.The thrombus was treated by post dilation with a non compliant balloon.It was stated that it is not known if the thrombus event was directly related to the use of the medtronic device as the event occurred immediately post procedure.The patient is reported to be fine.Event date updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Additional information: fluoroscopic images were provided for review.Initial images with contrast injection into the left coronary system confirm the target lesion at the bifurcation between the lad and d1.The lad section of the lesion was pre-dilated followed by pre-dilation of the d1 ostial lesion.A long stent was delivered and deployed to the lad.This was followed by post dilation of the lad and the d1 using kissing balloon technique.The thrombus can be seen at the bifurcation.The lad vessel was post dilated and this appeared to resolve the thrombus.There was no evidence of dissection or vessel damage as a result of the vessel treatment.Therefore the root cause of the thrombus could not be determined from the images provided.E.Initial's reporter first name updated.A.Patient information 3b.Gender: added.6.Annex d code added.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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