Catalog Number PC0520RXC |
Device Problem
Occlusion Within Device (1423)
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Patient Problems
Stroke/CVA (1770); Infarction, Cerebral (1771)
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Event Date 07/15/2013 |
Event Type
Injury
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Event Description
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A patient experienced an acute left hemisphere, watershed ischemic stroke approximately nine months after precise stent placement and experienced a myocardial infarction (mi), cardiac arrest, left internal carotid artery (ica) instent occlusion/restenosis, and irreversible anoxic bilateral brain injury approximately five days after three enterprise and one precise pro stent was implanted in the left ica.Prior to the stenting procedures, the patient presented with 90% stenosis of the left intracranial, distal cervical and cervical internal carotid artery with symptoms of slurred speech and word finding difficulty.She was treated with angioplasty and placement of a 5 x 20mm precise pro stent in the distal internal carotid artery that was post-dilated with a 3 x 30mm balloon.A 3.X 21mm wallstent was then deployed from the left internal to the left common carotid artery.There was 20% residual stenosis as well as persistent intracranial left internal carotid artery stenosis.Approximately nine months later, she presented with an acute left hemisphere watershed ischemic stroke and stent restenosis.She stopped taking aspirin and plavix 2 months previously.After angioplasty, three enterprise stents (one 4.5 x 37mm and two 4.5 x 28mm) were advanced into the distal ica through a prowler plus microcatheter.Stents were deployed starting from the cavernous ica proximally to the petrous internal carotid artery and connecting with her previous stent in the area.Following this, a 5.0 x 30mm precise pro stent was deployed between 2 cervical internal carotid stents.Post stenting runs showed good stent placement and no evidence of embolic event.The patient did well and was discharged to another facility the following day for treatment of multiple ongoing cardiovascular and medical problems that included coronary artery disease and stage 4 renal disease.
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Manufacturer Narrative
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While at the other facility, approximately 5 days after the stenting procedure, she suffered an mi with cardiac arrest.Following resuscitation and treatment with hypothermia, she was transferred back to the initial hospital.She underwent stenting of the mid and distal circumflex arteries.The patient was minimally responsive with extensor posturing to deep pain, and was on a ventilator.Ultrasound and ct suggested bilateral infarcts in the ¿watershed¿ distribution, and occlusion of the left ica at the skull base with no flow seen in the distal portion of the left ica stent, consistent with complete restenosis.The physician reported that it was difficult to know when the carotid occluded, and it is likely that occlusion was related to the interruption of flow associated with the cardiac arrest.No additional information regarding the patient¿s current condition could be obtained.The lot number of the device could not be obtained, therefore, the manufacture and expiration dates are also unknown.Information that it was a precise stent deployed on (b)(6) 2012 was received on (b)(4) 2014.Concomitant medications included: soma 350mg, aspirin 325mg daily atorvastatin 20mg daily, coreg 25mg twice daily, plavix 75mg daily lasix 20mg daily, novolog insulin 25 units with each meal, levemir insulin 24 units at bedtime, omeprazole 20mg daily, xanax 2mg 3 times daily, and metoclopramide 10mg with meals.Additional information will be submitted within 30 days of receipt.(b)(4).
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Manufacturer Narrative
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Complaint conclusion: a (b)(6)-year-old female patient with a history of congestive heart failure, coronary artery disease with past coronary bypass surgery and stenting, poorly controlled diabetes mellitus and hypertension, morbid obesity, and stage 4 renal disease on dialysis experienced an acute left hemisphere, watershed ischemic stroke approximately nine months after precise stent placement and experienced a myocardial infarction (mi), cardiac arrest, left internal carotid artery (ica) instent occlusion/restenosis, and irreversible anoxic bilateral brain injury approximately five days after three enterprise and one precise pro stents were implanted in the left ica.Prior to the stenting procedures, the patient presented with 90% stenosis of the left intracranial, distal cervical and cervical internal carotid artery with symptoms of slurred speech and word finding difficulty.She was treated with angioplasty and placement of a 5.0 x 20mm precise pro stent in the distal internal carotid artery that was post-dilated with a 3.0 x 30mm balloon.A 3.0 x 21mm wallstent was then deployed from the left internal to the left common carotid artery.There was 20% residual stenosis and persistent intracranial left internal carotid artery stenosis.Approximately nine months later, she presented with an acute left hemisphere watershed ischemic stroke and stent restenosis.She had stopped taking her aspirin and plavix approximately two months previous to the event.After angioplasty, three enterprise stents (4.5 x 37mm x 1 and 4.5 x 28mm x2) were advanced into the distal ica through a prowler plus microcatheter.Stents were deployed starting from the cavernous ica proximally to the petrous internal carotid artery and connecting with her previous stent in the area.Following this, a 5.0 x 30mm precise pro stent was deployed between 2 cervical internal carotid stents.Post stenting runs showed good stent placement and no evidence of an embolic event.The patient did well and was discharged to another facility the following day for treatment of multiple ongoing cardiovascular and medical problems that included coronary artery disease and stage 4 renal disease.Approximately 5 days after the stenting procedure, she suffered an mi with cardiac arrest and was resuscitated and treated with hypothermia.She was then transferred back to the other facility and underwent stenting of the mid and distal circumflex arteries.The patient was minimally responsive with extensor posturing to deep pain, and was on a ventilator.Ultrasound and ct suggested bilateral infarcts in the ¿watershed¿ distribution, and occlusion of the left ica at the skull base with no flow seen in the distal portion of the left ica stent, consistent with complete restenosis.The physician reported that it was difficult to know when the carotid occlusion occurred, and it is likely that occlusion was related to the interruption of flow associated with the cardiac arrest.No additional information regarding the patient¿s current condition could be obtained.The device was implanted and not available for analysis.In addition, the sterile lot number was not provided and review of manufacturing documentation could not be conducted.Thrombosis, cerebrovascular accident and restenosis are known potential adverse events associated with stent implantation procedures, and are listed in the ifu as such.The act of stent implantation produces intended damage to the intima of the vessel wall in order to remodel the wall and reestablish patency of the vessel.The disruption of the intimal layers triggers the immune system to heal the damaged areas, thus activating the clotting mechanism as well as the inflammatory response.The combination of inflammatory response and clotting cascade can lead to thrombus formation inside of the stent around the damaged areas.Occlusion/thrombosis/restenosis of the stent can results in decreased blood flow and distal embolization that can result in cerebral ischemia.However, this patient experienced an mi and cardiac arrest related to her pre-existing coronary artery disease, and the interruption of blood flow associated with the cardiac arrest may have contributed to the carotid occlusion and brain ischemia.The enterprise stent in intended for use with embolic coils and is not indicated for treatment of vascular occlusions, therefore, safety data for off-label use is not available.There is no evidence that the complaint was related to a design or manufacturing issue, therefore, no corrective actions will be taken at this time.This is one of five mdr reports that are being submitted for this complaint (sr# 1-1203857233).(b)(4).
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