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As reported, a cook-z gianturco-rosch tracheobronchial stent fractured in the inferior vena cava (ivc).The procedure involved retrieval of a celect platinum ivc filter, thrombectomy of the ivc and bilateral iliac veins, placement of kissing iliac vein stents, and placement of stents within the ivc.A venous thrombectomy was performed in the left iliac vein and ivc, just below the filter.Bilateral access was obtained, and a thrombectomy was performed on the right side.Right jugular access was then obtained, and the ivc filter was retrieved, using a loop-technique with a 16 french sheath.A thrombectomy of the ivc was then performed.Despite repeated advisement by a cook representative that the device was not intended for vascular use, the user then placed two cook-z gianturco-rosch tracheobronchial stents in the mid-to-distal ivc via right femoral access.Other manufacturers¿ 18-millimeter and 22-millimeter balloons were used to post-dilate the stents.Two cook zilver stents were then simultaneously placed in the right and left iliac veins, kissing the inferior z-stent that was deployed in the ivc.Another manufacturer¿s balloons were then simultaneously inflated within the zilver stents.After dilation, a venogram was obtained, noting that the left zilver stent appeared to be elongated or separated, as the distal zilver stent markers remained within the inferior z-stent and the proximal markers were sitting near the end of a pre-existing wall stent in the left iliac vein.The physicians then proceeded to dilate the superior z-stent with two balloons (other manufacturer) simultaneously, resulting in a lateral suture break of the superior z-stent (subject of this report).Blood flow was achieved through the zilver and z-stents.There were no adverse effects to the patient, and no additional procedures were required.The case was completed.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, a cook-z gianturco-rosch tracheobronchial stent fractured in the inferior vena cava (ivc).The procedure involved retrieval of a celect platinum ivc filter, thrombectomy of the ivc and bilateral iliac veins, placement of kissing iliac vein stents, and placement of stents within the ivc.A venous thrombectomy was performed in the left iliac vein and ivc, just below the filter.Bilateral access was obtained, and a thrombectomy was performed on the right side.Right jugular access was then obtained, and the ivc filter was retrieved, using a loop-technique with a 16 french sheath.A thrombectomy of the ivc was then performed.Despite repeated advisement by a cook representative that the device was not intended for vascular use, the user then placed two cook-z gianturco-rosch tracheobronchial stents in the mid-to-distal ivc via right femoral access.Other manufacturers¿ 18-millimeter and 22-millimeter balloons were used to post-dilate the stents.Two cook zilver stents were then simultaneously placed in the right and left iliac veins, kissing the inferior z-stent that was deployed in the ivc.Another manufacturer¿s balloons were then simultaneously inflated within the zilver stents.After dilation, a venogram was obtained, noting that the left zilver stent appeared to be elongated or separated, as the distal zilver stent markers remained within the inferior z-stent and the proximal markers were sitting near the end of a pre-existing wall stent in the left iliac vein.The physicians then proceeded to dilate the superior z-stent with two balloons (other manufacturer) simultaneously, resulting in a lateral suture break of the superior z-stent (subject of this report).Blood flow was achieved through the zilver and z-stents.There were no adverse effects to the patient, and no additional procedures were required.The case was completed.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states that the device is not intended for intravascular use.The ifu warns that the safety and effectiveness for use in the vascular system has not been established and can result in serious harm and/or death.The ifu also instructs not to attempt to balloon-expand the stent after deployment.The information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that intentional off-label use contributed to this incident.The instructions for use (ifu) clearly state that the device is not intended for vascular use.Furthermore, the ifu warns ¿the safety and effectiveness of this device for use in the vascular system has not been established and can result in serious harm and/or death.¿ the ifu also cautions the user ¿do not attempt to balloon-expand the stent after deployment.¿ per the reporter, the user was also told multiple times during the procedure that the device was not intended for vascular use.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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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