|
Model Number PXB35-07-27-135 |
Device Problems
Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/14/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Physician intended to use a visi pro balloon expandable stent system with a non-medtronic 6fr sheath and 0.035 non-medtronic guidewire during treatment of a calcifies lesion in the patient¿s proximal left subclavian artery.Moderate vessel calcification and tortuosity are reported.Lesion exhibited 90% stenosis.No damage noted to product packaging prior to use.No issue was noted when removing the device form the packaging.Device was prepped as per ifu.The modified seldinger technique was used.A (vert) catheter was used to selectively engage the left subclavian artery.Angiography was performed.Heparin was used for anticoagulation.Intravascular ultrasound (ivus) interrogation of the left subclavian was performed to help guide the intervention.By ivus a near total/sub-total occlusion was described.The ivus catheter was unsuccessful in crossing the lesion.Pre-dilation was performed using a 3mm medtronic balloon.The device was not passed through a previously deployed stent.No resistance was noted during advancement, but it is reported the stent could not pass the lesion.The device was removed from the patient and the physician noted the stent was not on the balloon but had sheared off.An attempt was made to position the dislodged stent unsuccessfully due to heavy calcification.Pre-dilation was then performed using a 6mm balloon followed by an 8mm balloon.The dislodged stent could still not be advanced into the stenosis.The dislodged stent also was unable to be withdrawn back into the sheath, so it was pulled back under fluoroscopy and deployed in the right external iliac artery.The stent was then post-dilated with an 8mm balloon.A self-expanding stent was then used to treat the lesion in the patient¿s subclavian artery.A medtronic balloon expandable stent was placed proximal to the self-expanding stent in an overlapping fashion to cover the true ostium of the left subclavian artery which was described as being very heavily calcified.The stents were post-dilated with a 8mm balloon.Stenosis is reported to have been reduced from 90%+ pre to less than 10% post intervention.Angiogram was performed and confirmed good flow and no evidence of dissection thrombosis or embolization.The 6fr sheath was removed and hemostatis was achieved using a closure device an standard technique.There was no patient injury reported.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Additional information: there was no vessel trauma noted as a result of the reported issue and no further treatment was required.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.
|
|
Search Alerts/Recalls
|
|
|