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Model Number AB46 |
Device Problems
Inflation Problem (1310); Migration or Expulsion of Device (1395)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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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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Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the reliant device.The exact size of the device is unknown.Survey results from an vascular surgeon in in practice 7 years, who has used the reliant device for expansion of vascular prostheses 45 times in total of which 15 of those times were in the last 12 months.For the temporary occlusion of large vessels it was used 15 times in total of which 5 of those were in the last 12 months.During use of the reliant for expansion of vascular prostheses (assisting in the expansion of self-expanding stent grafts), the foll owing complications were encountered; aneurysm (pseudoaneurysm at the puncture site after percutaneous procedure), inability to inflate/deflate balloon (balloon could not be completely deflated), stent graft migration caused by balloon catheter device (slight migration of the stent graft by hooking the applicator).The physician found the aneurysm events somewhat concerning, inability to inflate/deflate balloon not at all concerning and the stent graft migration caused by balloon catheter device not at all concerning.All of the adverse events reported were deemed to be related to the device on at least one occasion each.During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; entry site infection ( wound infection after open access), cardiac events (arrhythmia after blocking the vessel with a balloon).The physician found the entry site infection event and cardiac events somewhat concerning.The cardiac event was deemed to be related to the device itself.Of the above complications reported, some of these are listed as having been reported to medtronic previously.Due to limited information these are included in reporting.No further information has or will be provided.
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Manufacturer Narrative
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B:5 additional information received.It was reported that for the expansion of vascular prothesis, the physician also encountered aneurysm rupture (aneurysm on vascular access after percutaneous puncture).The physician found this event somewhat concerning.This event was found not to be related to the device itself.H:6 updated.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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Search Alerts/Recalls
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