COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
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Catalog Number PRP35-08-040-120 |
Device Problems
Premature Activation (1484); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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A protege everflex was intended to be used.A patient was in for an abdominal aortic implantation.Four fenestrations (planned double-kidney covered stent, bare stent for superior mesenteric and celiac trunk).During the surgery, an everflex8-40 stent was used in the superior mesenteric artery first.A second everflex8-40 stent was then prepared to be placed into the celiac trunk through the same approach (7f non-mdt long sheath).The stent was opened and observed normally, the lock was normal.A 0.035" guidewire was used.When the guide wire was inserted, it felt stagnant compared to the previous stent, continued pushing, when it reached the sheath buckle, they felt a lot of resistance.When trying to continue pushing, the stent was partially dislodged.Premature deployment had occurred in vitro.Checked that the safety latch was not opened.Attempted to push back but failed, so the guide wire was withdrawn and discarded.Changed to other brand of consumables, and finally the surgery was successfully completed.
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Manufacturer Narrative
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Product analysis the device was returned with the manifold safety locking pin tight.The deployment paddles are approximately 47mm apart the device was received with approx.16mm of the distal end of the stent exposed a 20cc water filled syringe was used to flush the device, both annual spaces flushed and a 0.035¿ guidewire was loaded the proximal deployment paddle was pinned, and the distal deployment paddle was pulled to fully expose/deploy the stent.The stent was examined, and it was found to de deformed from being previously exposed during the procedure.The distal inner assembly was cut just proximal to the stent retainer to allow further testing.A set of witness marks were noted on the stainless steel hypotube approximately 25mm and 27mm from the distal end of the stainless steel hypotube; indicating that the safety locking pin was properly tightened during manufacturing.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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