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Physician intended to use an inpact admiral drug coated balloon with a 6fr non-medtronic sheath and non-medtronic 0.014 guidewire during patient treatment.Vessel status described as stenosed.Ifu was not followed.No issues were noted when removing the device from the product packaging.Device was prepped without issue.It is reported a contralateral approach was used.It is reported wire movement issues occurred.The inpact admiral was attempted to be delivered with the non-medtronic 0.014 wire but resistance was encountered prior to reaching the lesion.The device was not passed through a previously deployed stent.The physician tried to replace the guidewire, while keeping the inpact in place but, the wire became stuck in the device and removal difficulties were encountered.The balloon was not inflated in the patient.The wire and dcb were removed in tandem and an unplanned bailout stenting was performed.It is reported a wait-and-see judgement was applied to the patient¿s condition.Plain old balloon angioplasty (poba) was reported to have been performed well so the procedure was completed.Should stenosis occur in future treatment will be considered.No vessel damage occurred.No further patient injury reported.
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Product analysis: the inpact admiral device was returned to medtronic investigation lab for evaluation along with a 0.014 inch guide wire loaded in the device.Hardened residue blockage was evident surrounding the guide wire distal to the distal tip.An attempt was made to retract the guide wire proximally through the device, however resistance was met at the hardened blockage distal to the tip.The guide wire was advanced distally with resistance noted, and further hardened residue blockage was evident along the length of the guide wire.The guide wire was removed through the distal tip of the device.No other device damage or abnormalities were noted.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.
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