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As reported by the sapphire ww study, during the procedure one of the angioguard failed to cross the lesion before placement of the stent in left side of the heart.4 days later, the (b)(6) male patient had aphasia which was diagnosed as a tia.The recovery was partial with minor residuals.The patient was discharged 5 days later.Medical history included synchronous, prior carotid endarterectomy (right and left), cardiac and carotid disease requiring open-heart surgery and carotid revascularization, hyperlipidemia, clinical copd, history of smoking (>5packs of cigarettes) and coronary artery disease.At study inclusion, the nih and rankin were 0.It was reported that the patient was asymptomatic pre-procedure.The procedure was to place two stents in the bifurcation of the right and left common carotid artery.The initial procedure was performed on an 80% occluded lesion in the bifurcation of right common carotid artery of 30 mm in length and 8 mm vessel diameter with mild vessel tortuosity.The arch ii was eccentric with mild calcification.A 5mm medium support angioguard rx embolic protection device was successfully deployed past the lesion, and pre-dilatation was performed.An 8x40mm precise pro rx stent was successfully deployed at the target lesion.The angioguard rx was successfully retrieved and it was unknown whether debris was present in it.There was no documented dissection or presence of air bubbles.The residual diameter stenosis measured 0%.During the other procedure the target lesion was bifurcation of the left common carotid artery.The procedure was performed on 90% occluded lesion of 30mm in length and 8mm in diameter.The lesion was resistant to pta.There was no documented vessel tortousity.An attempt was made to advance a 5mm medium support angioguard rx embolic protection device through the lesion but it was reported that the angioguard failed to cross the lesion.The angioguard was successfully retrieved and a non-cordis embolic protection device was passed through the lesion and was deployed successfully.The angioguard was prepped according to ifu instruction.There was no evidence of kinks or damage prior to insertion.The lesion was pre-dilated and an 8x40mm precise pro rx stent was successfully deployed at the target lesion.The angioguard was successfully retrieved.The patient was neurologically intact upon leaving the angio suite.There is no indication if the patient was discharged following the procedures.The patient had a tia four days later.At discharge 5 days after the adverse event, the nih stroke scale score was 2 and the rankin score was 4.Intra-procedure medications included heparin.Aspirin was given pre and post-procedure.Clopidogrel was given post procedure.At the 30 day follow-up, nih and the rankin scores were 0.Post procedure medications were ongoing.The patient also exited the study after having completed all of the required follow up.No changes required to the file type or determination.The second 8x40mm precise pro rx stent also remains implanted and is thus not available for analysis.A review of the manufacturing records could not be conducted without a lot number.Based on the information available for review, there are vessel characteristics (calcification), that may have contributed to the event reported failure to cross of the angioguard device.Without the return of the device for analysis, the reported customer complaint could not be confirmed.Neither the dhr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken.Tia is a well-known potential adverse event associated with the carotid stent implantation procedure and is listed in the ifu as such.Tia is often associated with a temporary stoppage or slowing of blood flow to the cerebral arteries.The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may collect in the embolic protection device or flow downstream potentially disrupting perfusion both during and after carotid stent implantation.By definition (mayoclinic.Org), the symptoms of a tia may last up to 24 hours, but they often last only a few minutes.Tia occurs when the blood supply to part of the brain is briefly interrupted.Tia symptoms are similar to those of stroke but do not last as long.Most symptoms of a tia disappear within an hour.There is no evidence that manufacturing issues contributed to the event.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.This is one of products involved with the reported adverse event and are associated manufacturer report numbers 9616099-2014-00177 and 9616099-2014-00178.
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As reported by the (b)(4) study, the adjudication minutes received indicate a patient became severely hypertensive with systolic blood pressure of 300 and very anxious which was treated with sedation and subsequent intubation when the angioguard was in place for the initial procedure in the right cca.Four days later, the patient had aphasia which was diagnosed as a tia but classified as cva also by the adjudication committee.The recovery was partial with minor residuals.The patient was discharged 5 days later.The patient is a (b)(6) man with a history of synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization, dyslipidemia, smoking, cad, and bilateral cea.At study inclusion, the nih and rankin were 0.It was reported that the patient was asymptomatic pre-procedure.The procedure was to place two stents in the bifurcation of the right and left common carotid artery.Post catheterization, he had ¿no evidence of cerebral event as he was moving everything and completely wide awake¿ but did became very anxious.Anesthesia gave him sedation which ultimately required intubation because of his low saturations.When his blood pressure came down below 200, the operator proceeded with the procedure given that the angioguard¿ rx was already in place.The initial procedure was performed on an 80% occluded lesion in the bifurcation of right common carotid artery of 30 mm in length and 8 mm vessel diameter with mild vessel tortuosity.The arch ii was eccentric with mild calcification.A 5mm medium support angioguard rx embolic protection device was successfully deployed past the lesion, and pre-dilatation was performed.An 8x40mm precise pro rx stent was successfully deployed at the target lesion.The angioguard rx was successfully retrieved and it was unknown whether debris was present in it.There was no documented dissection or presence of air bubbles.The residual diameter stenosis measured 0%.During the other procedure the target lesion was bifurcation of the left common carotid artery.The procedure was performed on 90% occluded lesion of 30mm in length and 8mm in diameter.The lesion was resistant to pta.There was no documented vessel tortuosity.During the second procedure, the angioguard did not cross and a non cordis embolic protection device was used.The angioguard was successfully retrieved and a non-cordis embolic protection device was passed through the lesion and was deployed successfully.The angioguard was prepped according to ifu instruction.There was no evidence of kinks or damage prior to insertion.The lesion was pre-dilated and an 8x40mm precise pro rx stent was successfully.In the recovery room, the patient developed chest pain with st elevation.Cardiology was consulted and cardiac catheterization was performed on the same date, revealing a 90% stenosis in the lmca, a 75% stenosis in the lad, an 85% stenosis in the 1st diagonal, a 50% stenosis in the cx and less than 50% stenoses in the rca.Ef was 70%.The cabg surgery was on the same date on the patient underwent successful percutaneous treatment in the left carotid artery with pre-stent balloon angioplasty and placement of one stent, using an embolic protection device.A high-grade lesion in the left subclavian artery was successfully treated with balloon angioplasty and placement of a stent.The procedure was uncomplicated.The patient was transferred back to the recovery room in stable condition.The patient had a tia four days later that was classified as cva.At discharge, the nih stroke scale score was 2 and the rankin score was 4.Intra-procedure medications included heparin.Aspirin was given pre and post-procedure.Clopidogrel was given post procedure.At the 30 day follow-up, nih and the rankin scores were 0.Post procedure medications were ongoing.The patient also exited the study after having completed all of the required follow up.No changes required to the file type or determination.On post-operative day #1 two days later, the patient was awake and alert and moving all four extremities.The progress note on the following day at 12:27 reported: st evaluation completed.The patient presents with receptive and expressive deficits.St to initiate treatment.St also noted overt signs of aspiration by bedside.The progress note on at 14:21 reported: ot evaluation complete.The patient with increased difficulty with self-care tasks, decreased ability to consistently follow commands; the patient appeared confused.The progress note on at 15:15 reported: pt evaluation complete.The patient is very confused, unsafe, restless, resistant to sit, grabbing handrails and trying to climb out of bed, unable to follow commands or express desires, answer questions or follow commands, resistant to lay down (may be appropriate to rehabilitation when more stable).Progress note by vascular surgery on the following day at 08:00 noted: right-sided numbness/confusion since cabg, right arm/leg ¿ decreased motor.Order: mri, neurology consult, carotid duplex.The patient was also noted to have slurred speech.The nih stroke scale score was not evaluated at the time of event, as reported by the site.Per discharge summary description of event, post-cabg the patient experienced some slurred speech and unilateral weakness.There was no facial palsy and deep tendon reflexes were intact.Carotid ultrasound report was requested from the site for this event, and the site responded: ¿no carotid us performed.¿a stat head ct scan at 08:53, compared to study in 2011, revealed age indeterminate but probably remote small lacunar infarcts in the left cerebellum.No mass or hemorrhage was noted.Neurology consultation was performed on (b)(6) 2014.At the time of consultation, the patient was awake, alert and aware; he was slurring his speech; speech ¿seemed to be better¿ at the time of consultation, as compared to early morning according to his brother.Neurological examination revealed mildly slurred speech.There was no facial palsy.Dtr were 2+.Babinski¿s sign was negative bilaterally, and the patient was moving all extremities.Neurology progress note on the following day at 08:40 reported: 3/5 rue, 2/5 rle.Per further notes, rt was upgoing, lt was downgoing, and he had dysarthria.A brain mri (dwi) on the following day revealed innumerable tiny foci of restricted diffusion throughout the left cerebral hemisphere and left cerebellum; the largest in the cerebellum measured 8 mm.The largest focus in the supratentorial left brain measured 11 mm in the left temporal lobe.Tiny punctate focus in the pons to the right of midline was also identified.Radiology report impression: multiple small foci of restricted diffusion in the left cerebellum and left cerebral hemisphere, the largest focus in the cerebellum measured 8 mm; the largest focus in the cerebrum measured 11 mm.No associated mass effect was evidence.There was a tiny focus suspected in the right pons; another tiny focus on the right in the gray-white junction in the centrum; not clearly an acute infarction.No midline shift or hemorrhage was suspected.Pre-discharge, the nih stroke scale score was 2 due to left arm and left leg drift.The rankin stroke scale score was 4; note: ¿status post cabg, so walking decreased.¿ the discharge summary reported: possible cva was confirmed.The patient was discharged to a rehabilitation facility on (b)(6) 2013 on asa and clopidogrel.The neurological event form reported this event as a tia with deficits that lasted greater than 24 hours and resolved.At 30 day follow-up visit (approximately one month later), the nih stroke scale score was 0 and the rankin stroke scale score was 0.(b)(4): the product remains implanted and is thus not available for analysis.Device history record (dhr) review was not conducted as the sterile lot number was not provided.Cerebrovascular accident is a known potential risk associated with implanting a stent in a carotid artery and is listed in the ifu as such.It can be defined as a cerebrovascular disorder caused by deprivation of blood flow to an area of the brain, generally as a result of thrombosis, embolism, or reduced blood pressure.The act of stent expansion or post-dilatation, to optimally oppose a carotid stent to the vessel wall, temporarily obstructs blood flow to the cerebral arteries (ischemic process).The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may travel upstream to the cerebral arteries potentially disrupting perfusion.This act, inherent to the procedure may have contributed to the reported event.A blood vessel that is not blocked, but is extremely narrowed, can also cause an ischemic stroke.The blocked or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death.Eighty % of all strokes are ischemic.During ischemic stroke, diminished blood flow initiates a series of events (called ischemic cascade) that may result in additional, delayed damage to brain cells.Early medical intervention can halt this process and reduce the risk for irreversible complications.There is no evidence that manufacturing issues contributed to the event.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.This is one of three devices associate involved with the reported adverse event and are associated manufacturer report numbers 1016427-2014-00106, 9616099-2014-00177 and 9616099-2014-00178.
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