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Physician implanted abre self-expanding stent in the mid to proximal superior vena cava (svc) with 80-90% stenosis during procedure.The vessel had little tortuosity.The vessel diameter is reported at 22 - 18mm and lesion length as 60mm.During procedure, non-medtronic 9fr sheath and glidewire were used.No embolic protection used.There was no damage noted to packaging.There was no issue when removing device from hoop/tray.The device was prepped per ifu with no issues identified.The was no alleged product issue.The lesion was pre dilated using a non-medtronic 20x40 pta balloon.The device did not pass through a previously deployed stent.No resistance encountered when advancing the device.It was reported that a 20x40 non-medtronic balloon was utilized to pre-dilate the lesion.The first 9fr 23 cm non-medtronic brite tip sheath was removed because the non-medtronic balloon after dilation would not retract from the sheath and was stuck in it.A second sheath was inserted and a second new 20x40 non-medtronic balloon was used.The 20x80 abre stent was then placed with very good success and then was post-dilated with the 20x40 non-medtronic balloon.There were no abnormalities angiographically around the stent noted.After post dilation, the patient's blood pressure dropped.The physician then checked for a pulmonary embolization and found nothing.Physician then scanned the chest and found potential blood in the pericardium.A drain was placed to withdraw the blood from the pericardium with success.The patient's blood pressure rose and stabilized.The ct surgery fellow came to view the images with the physician and additional diagnostic images at different angles were taken of the stent in the svc.The ct surgery fellow noted to the physician that there seemed to be nothing that need to be repaired.The drain was left in and the patient was going to be monitored post procedure, however after moving the patient from the procedure table to the hillrom bed for transport, patient coded and was then resuscitated.Patient was then transported to icu for further evaluation.This case was originally scheduled with a physician as he reached out to medtronic rep to discuss and obtain a stent.Another sales rep was able to get stents available for the following day.Physician asked about the differences in this stent as compared to the non-medtronic stent and sales rep noted that the stent was designed to be more accurate in deployment and more durable and provide the performance characteristics that are needed in the illio-femoral segment.Sales rep consulted on the actual use of the stent only and not in the overall procedure.Ultrasound was used in this case to measure the vein and occlusions but the information was not shared.The patient had a diagnostic procedure the day before and a plan was already developed.During the code of the patient a fellow walked in and knew the history of this patient.This patient apparently was riddled with tumors and was in pallative care.It is unknown if maybe the occlusion could have been a tumor or not.Patient status is unknown at follow up one day post procedure.Patient suffered complication of haemorrhage/bleed.The patient had pericardial blood and fluids removed post procedure.It was reported that physician noted that post dilation one-to-one was not carried out and thinks the occlusion noted was a tumor.The vessel sizing using ivus was not made available for review.Previous to the case the fellows and the physicians were discussing sizes that they thought it was from the previous diagnostic case the day before procedure and agreed upon a 20mm diameter stent.It is not clear if any ivus was used the day before or not to measure diameter.Physician reported patient expired.
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Image review six cine images were provided for analysis.No device or ancillary devices were returned for analysis.The device remains in the patient and is not expected to be return for analysis.The images provided are from the implant procedure.The first image is pre procedure and shows the supervisor vena cava (svc) prior to stenting.The second and third images are of a pta non-medtronic device being inflated in the patient¿s proximal superior vena cava.The fourth, fifth and sixth image are of the abre stent implanted in the patient¿s proximal superior vena cava.In none of the images provided does it appear that a stent strut lacerated the superior vena cava to cause the blood found in the pericardium or that the abre stent could have contributed to the patients death.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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