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The physician attempted to use an abre stent to treat a the fibrous, chronic total occlusion in the left ivc, common iliac vein, external iliac vein.It is reported deployment issues were encountered and the stent partially deployed.Artery diameter was 18-19 mm and lesion length was 180 mm.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu, with no issues identified.Left popliteal access with patient prone under ultrasound guidance, 9fr non-medtronic sheath placed.Venogram from popliteal to iliac veins, showing no contrast above mid cfv, with large pelvic vein collateral branching off medial to cto.After unsuccessful canulation with several.035 wires, an.018 non-medtronic wire was passed successfully through the left iliac veins into the ivc, with help of an.018 non-medtronic catheter.Switched to.035 non-medtronic catheter to ivc over.035 non-medtronic wire.8mmx80mm evercross balloon tracked up to level of distal civ, with nominal pta inflations done along entire segment from that location down to cfv.Due to inability to pass 8x80 balloon to level of ivc confluence, a 5x120 non-medtronic balloon was next, successfully crossing to ivc, and inflated to nominal atm from confluence down to cfv.8x80 evercross put back in, successfully crossing to ivc, with repeated nominal inflations from confluence down to cfv.Due to nature of apparent chronic thrombus and severe fibrosis, sheath was swapped out for an 11fr sheath and a non-medtronic mechanically thrombectomy catheter was used from cfv up to level of confluence, with no apparent issues with tracking along wire.After non-medtronic thrombectomy catheter removal,.035 non-medtronic catheter was used to exchange out kinked.035 non-medtronic wire to an.035 non-medtronic wire.Attempted to track.035 non-medtronic ivus, but ivus would not track past mid to left civ.An 8fr 90 cm non-medtronic shuttle sheath was placed, with its introducer, over the non-medtronic wire through the 11 fr non-medtronic sheath, successfully crossing through left civ into distal ivc with no apparent issue or resistance.Ivus was placed through 8fr shuttle sheath, with imaging component placed into distal ivc and pullback ivus performed while pulling back 8fr shuttle sheath concurrently.Ivus and 8fr sheath removed, leaving 11fr with non-medtronic wire in place.Ivus appeared to show very narrowed left civ, eiv, and cfv, with difficulty in visualizing healthy reference vessel sizing.Ultrasound-guided access was obtained in the right popliteal, with placement of 9fr sheath, wire placed up to svc.Ivus performed on right iliac veins to utilize as vessel sizing reference for stent placement in left iliac veins.Right civ measured 18-19mm in diameter, so the physcians determined 20mmx120mm abre stent would be used.Additional pre-dilitation of the left civ, eiv, and cfv was performed with a 10mmx60mm evercross, to nominal pressure without any difficulty.20x120 abre was prepped appropriately and placed over non-medtronic wire through 11fr sheath on patient¿s left side, tracking without any notable resistance into distal ivc just above level of confluence.Upon confirmation of location of confluence with the help of a venogram performed through catheter placed in right civ from the patient¿s right-sided access, abre was placed with distal end just above confluence for deployment.The red locking pin was removed without issue and deployment was initiated.The rolling thumbwheel turned with normal force to deploy the first 25-30mm of the stent, with wall apposition in the noted in the distal left civ, landing as intended.Then heavy resistance was noted in the thumbwheel and the physcians took turns attempting, with extra force, to turn the thumbwheel in order to complete deployment as they were already committed to stent placement and retrieval was not possible.With the few extra clicks of the thumbwheel, the distal to mid portion of the stent that had deployed was not opening to the intended size and appeared severely crimped in comparison to the distal stent portion that landed successfully above it.The rubber ridging on the thumbwheel was eroding, minimizing ability to grip thumbwheel for additional attempts to deploy stent.Attempts to reposition stent delivery system were unsuccessful.The physcians determined normal thumbwheel deployment was no longer achievable and disassembled the abre delivery system handle in hopes to be able to manually pull the inner string back and complete stent deployment, without success.Additional left popliteal vein access was achieved, and an.018 non-medtronic buddy wire was successfully placed alongside the abre delivery system.A 6mm (unknown length).018 non-medtronic balloon was placed over the.018 buddy wire and inflated adjacent to the undeployed portion of the abre in hopes the balloon would relieve pressure on the delivery system and the stent would be able to deploy.This was unsuccessful with the balloon location varying in multiple attempts.A vascular surgeon was consulted and came to the room for additional ideas.Multiple attempts were made by the physcians to remove additional portions of the triaxial delivery system of the abre in order to somehow use a pin-pull method to deploy the rest of the stent, without success.After multiple ideas were exhausted from all physicians and staff present, the decision was made to leave the remaining abre stent delivery system in place and the patient was sent to surgery for foreign body removal as the stent delivery system was left in patient.There was no damage to the deployment mechanisms or device handle prior to deployment issue and the thumbscrew/lock-pin was checked for securement prior to procedure.
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Additional information: the 8x80 evercross was used successfully.Patient is doing well and recovering.Open surgery was used to remove the device.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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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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