COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY
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Model Number EVD35-06-150-120 |
Device Problems
Fracture (1260); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician used an everflex entrust self-expanding stent with a non-medtronic 7fr sheath and 0.014 non-medtronic guidewire during treatment of a 150mm calcified lesion in the patient¿s distal right superficial femoral artery (sfa) of diameter 6-7mm.Moderate vessel calcification was reported.Lesion exhibited 90-99% stenosis.There was no damage noted to the packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.Pre-dilation was performed using a 4mm pre-dilation device.No resistance was noted during advancement.The device was not passed through a previously deployed stent.It is reported that during delivery of the device, the distal portion of the stent was deployed correctly, but the proximal portion separated and was retained by the delivery device despite the thumb wheel continuing to rotate.The device catheter became stuck on the wire and the device and wires movements caused the proximal segment of the stent to fracture and completely separate.The detached portion remains in the patient.A second everflex entrust stent was opened and prepped as per ifu without issue.A 7fr sheath and 0.035 non-medtronic sheath were used.This device was introduced to cover the previously fractured stent however, when the second stent attempted to telescope into the first it became hung up on the fractured portion of stent and the tip of delivery catheter was deformed.This device was replaced with an additional 6x 100mm stent which crossed into the fractured stent.It passed without issue and was deployed.No further injury reported.
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Manufacturer Narrative
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Additional information: the majority of the first stent had deployed and the fracture was reported to be clean, requiring no snaring to be done.The second stent was not able to be deployed.Attempts were made to pass into the defective stent but the catheter could not enter into the stent.After several attempts, the device was removed undeployed.The tip was examined, which a portion of the tip was flared away from the wire.There was no apparent damage to the vessel.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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Manufacturer Narrative
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Image review: three photographic images were received for review.The first two images are of the distal end of the entrust stent delivery system removed from the patient.In the two images, the entrust stent delivery system appears to be loaded onto a guidewire that is less than 0.035¿ in diameter.Per the initial reported event description, the guidewire used was 0.014¿ in diameter.The stent fragment protruding from the distal end of the entrust stent delivery system catheter appears to be tensile elongated and fractured.The third photographic image is of a cine image.The implanted everflex stent segment appears to be tensile elongated and fractured.It is noted that no guidewire is visible in the image.It appears that the guidewire was removed with the entrust stent delivery system.Per the initial reported event description, the entrust stent delivery system became stuck together and were removed in tandem.Product analysis: the device returned loosely coiled inside 4 biohazard bags.A 0.014¿ guidewire returned locked in device.The device was decontaminated with cidex opa solution soak and tergazyme soak.The device was returned with the red safety tab removed from the handle but not returned with the device.The device was returned with the distal end of stent exposed and damaged, tip damaged and 0.014¿ guidewire exiting distal end of device.The device was returned with multiple kinks along the shaft.The deployment wheel could not be turned, and no functional testing could be carried out due to the condition of the returned 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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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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