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The below description of a serious injury using pva foam embolization particles was taken from the following article: padgett et al., ¿anterior cord syndrome after embolization for malignant hemoptysis.¿ seminars in interventional radiology.36.2 (2019): 111-116.The following is stated in the article: "a (b)(6) female presented with stage iv adenocarcinoma of the lung was referred to interventional radiology (ir) clinic for bronchial artery embolization (bae) for recurrent hemoptysis." embolization of several intercostal arteries was performed using 300 to 500 ¿m polyvinyl alcohol (pva) particles (pva-300).After awakening from the procedure, the patient complained of not being able to move her legs, despite having intact sensation."approximately 2 hours later, after awakening in the recovery area, the patient complained of not being able to move her legs, but was found to have intact sensation and rectal tone.Mri of the thoracic and lumbar spine was obtained approximately 4 hours after the end of the procedure, showing no abnormal thoracic or lumbar cord signal to suggest infarction.Neurosurgery was consulted.The patient was transferred to the icu, where a lumbar drain was placed for perfusion.Intravenous steroids and strict blood pressure control were initiated." "two days later, the patient had persistent flaccid paralysis of her legs and a repeat mri of the entire spine was performed.Mri was notable for interval development of edema along the anterior horns of the spinal cord from c5¿c6 to t4¿t5 (fig.4a¿c), consistent with a cord infarction.Of note, a disc osteophyte complex compressing the thecal sac was present at c6¿c7 (fig.4a).Her neurological exam was notable for a sensory level at the umbilicus, corresponding to around t4¿t5, flaccid paralysis in the lower extremities, and subjective paresthesia of the left hand which she reported unchanged from preprocedure.No motor abnormality of the upper extremities was present." "the patient spent 1 week in the hospital following the procedure and was then discharged to a skilled nursing facility with persistent lower extremity paralysis and resolution of hemoptysis." no other adverse effects were reported for this incident.
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Investigation ¿ evaluation: cook was informed on 04feb2022 of an incident involving a pva-300 (pva foam embolization particles) from an unknown lot.It was reported as part of a journal article titled ¿anterior cord syndrome after embolization for malignant hemoptysis¿ a 45-year-old female presented with stage iv adenocarcinoma of the lung was referred to interventional radiology (ir) clinic for bronchial artery embolization (bae) for recurrent hemoptysis.Embolization of several intercostal arteries was performed using 300 to 500 m polyvinyl alcohol (pva) particles (pva-300).After awakening from the procedure, the patient complained of not being able to move her legs, despite having intact sensation.Mri of the thoracic and lumbar spine was obtained approximately 4 hours after the end of the procedure, showing no abnormal thoracic or lumbar cord signal to suggest infarction.Neurosurgery was consulted.The patient was transferred to the icu, where a lumbar drain was placed for perfusion.Intravenous steroids and strict blood pressure control were initiated.Two days later, the patient had persistent flaccid paralysis of her legs and a repeat mri of the entire spine was performed.Mri was notable for interval development of edema along the anterior horns of the spinal cord from c5¿c6 to t4¿t5 (fig.4a¿c), consistent with a cord infarction.Of note, a disc osteophyte complex compressing the thecal sac was present at c6¿c7.Her neurological exam was notable for a sensory level at the umbilicus, corresponding to around t4¿t5, flaccid paralysis in the lower extremities, and subjective paresthesia of the left hand which she reported unchanged from pre-procedure.No motor abnormality of the upper extremities was present.The patient spent one week in the hospital following the procedure and was then discharged to a skilled nursing facility with persistent lower extremity paralysis and resolution of hemoptysis.Reviews of the documentation, including the complaint history, device history record and instructions for use (ifu) of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Although a lot number was not provided by the facility, a review of the sales history for this customer was able to identify three possible lots for this event.A review of the device history record (dhr) for lots 7621977, 7697493, and 9136811 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with these final product lot numbers.Cook also reviewed product labeling.The current instructions for use [t_pva_rev9] state the following: "intended use polyvinyl alcohol foam embolization particles are intended for embolization of the blood supply to hypervascular tumors and arteriovenous malformations, including use in intracranial embolization.The product is intended for use by physicians trained and experienced in embolization procedures in the targeted area.Standard techniques for embolization procedures should be employed.Contraindications presence or suspected presence of severe atheromatous disease.Presence or suspected presence of unfavorable patient anatomy, such as vascular configurations that do not allow superselective catheter placement.Inadequate vessel diameter to accept emboli.Vascular resistance peripheral to the feeding vessels that will not allow emboli to be carried into the lesion.Inappropriate vascular anatomy such as feeding vessels smaller than the distal branches from which they emerge.Inappropriate vascular anatomy such as extra-to-intracranial anastomoses or shunts.Inappropriate vascular anatomy such as the presence of collateral vessel pathways that, if embolized, could endanger normal tissues.Presence or likely onset of hemorrhage.Presence or likely onset of vasospasm.Patient intolerance to temporary occlusion of targeted vessels.Presence of target vessels leading directly to cranial nerves.Warnings: neurological deficit, ischemic stroke or ischemic infarct can occur from occlusion of normal vessels by emboli.Precautions: use of artificial embolization devices requires careful evaluation of the vascular network associated with the lesion.Smaller particles are reported to be more likely to cause cranial nerve palsies and ischemic infarction because of their ability to block vessels at the precapillary level.The physician's experience must be the final judge as to the amount of the device to use, the size of the particles to use, and even whether a treatment should be undertaken.Performing therapeutic embolizations deliberately to occlude blood vessels is a high-risk procedure.Appropriate facilities should be available for coping with the potential complications of the procedure.Emboli of appropriate size must be selected by the physician, based upon the lesion to be treated and the measurements from angiography.Potential adverse events: passage of emboli through the lesion and into normal vasculature, resulting in normal tissue damage.As with any embolization device, patient injury including permanent disability or death may occur as a result of its use.Instructions for use: 1.Prior to use, quality baseline angiography is essential to determine the vascular supply to the lesion in question.The angiogram should demonstrate the route of catheter entry and should be extensive enough to allow the physician to plan the entire interventional procedure.Extreme care should be taken to search for potentially dangerous collateral pathways.2.Following percutaneous entry of the vascular system (generally by seldinger technique), the carrier catheter is introduced as close as possible to the hypervascular lesion.Good runoff can be assured with real-time fluoroscopy.3.After properly positioning the catheter, the physician should inspect the embolization particles.The appropriate size particles must be chosen based upon the lesion to be treated and the measurements taken from the baseline angiogram.There should not be a break in the package integrity; otherwise, sterility may be compromised.The particles should be visually inspected for uniformity of size.4.Approximately 10 cc of non-ionic contrast agent should be introduced into the bottle containing the embolization particles.Approximately 10 minutes should be allowed, with intermittent agitation, for adequate mixing of contrast and embolization particles.5.The physician should then inspect the particles to ensure that no part of the rubber stopper has been inadvertently introduced during the needle puncture of the vial.6.The physician should also inspect the catheter through which the embolization particles are to be delivered.There should be no tip taper on the delivery catheter.7.When the physician is ready to introduce the particles, a small amount of contrast agent should be the first injected through the delivery catheter to ensure that the tip has not moved and that adequate runoff exists.8.The particles are then withdrawn from the bottle into a small syringe (3 cc or larger to prevent excess pressurization of the delivery catheter).Intermittent agitation of the contrast/emboli mixture is recommended to ensure adequate suspension.Caution: catheter obstruction by emboli may result if particles are inadequately suspended in non-ionic contrast.Care should be taken to ensure that emboli are free-floating in a sufficient volume of contrast.9.The physician may then infuse the particles suspended in the contrast agent while directly watching the artery's acceptance of the contrast agent.Caution: as the treatment progresses, the artery will typically accept less and less of the contrast agent/embolization particle mixture.The physician must watch for this change and decrease the infusion accordingly.If this change is not appreciated, inadvertent reflux into critical arteries may occur, creating the potential for ischemic infarction.10.The physician must use his or her judgement in determining the endpoint of the infusion.Most physicians stop infusing particles before complete occlusion of the vessel, when the acceptance rate or forward flow is approximately 1 cm/sec.11.Upon completion of the treatment, particles will likely remain present within the catheter.The catheter should be removed from the patient with gentle suction upon it so that no particles are inadvertently lost during the withdrawal of the catheter.12.Should the catheter become plugged during the procedure, no attempt should be made to clean the particles from it; rather, the catheter should be removed from the patient and assessed for damage.13.Patient follow-up after the conclusion of the procedure is recommended to assess the continued level of vascular occlusion.Angiography may be indicated.Evidence gathered upon review of the dmr, dhr, and the product labeling, did not confirm that the device was manufactured out of specification or items in the lot or similar devices in the field or in house are nonconforming.Based on the information provided, no returned product and the results of our investigation, it was concluded that this failure is a known inherent risk of device usage.According to the ifu, passage of emboli through the lesion and into normal vasculature, resulting in normal tissue damage, and as with any embolization device, patient injury including permanent disability or death may occur as a result of its use.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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