MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number ENVEOR-N |
Device Problem
Difficult to Insert (1316)
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Patient Problems
Intimal Dissection (1333); Vascular Dissection (3160)
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Event Date 08/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: no product was returned. conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, via the transfemoral approach using the inline sheath, resistance was felt during insertion.Following the valve implant, a minor dissection of the iliac artery was noted.It was reported that the diameter of the artery was not large enough and there was calcification.A stent was implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Updated data: d8, g1, h6: annex e and annex f codes conclusion: the delivery catheter system (dcs) was not returned to medtronic for analysis, procedural images were not received.A device history record (dhr) review was performed on the dcs and there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The reported event indicated that resistance was felt during insertion of the dcs.Difficulties inserting the dcs through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.In this case, it was noted that the diameter of the artery was not large enough and there was calcification.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.The reported event also indicates that a dissection of the iliac artery was noted following the implant of the valve.Vascular access related complications, such as bleeding and dissection, are a known potential adverse patient effect per the evolut system instructions for use (ifu), and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).It was noted that the minimal diameter of the access vessel was 4.7 mm.Per the ifu ¿patients must present with transarterial access vessels with diameters that are =5.5 mm when using models enveor-n.Failure to implant a device within the sizing matrix could lead to adverse effects including cardiovascular injury¿.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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Additional information was received indicating that the right side was used as the access site and was the side of the dissection.It was noted that the minimal diameter of the access vessel was 4.7 mm.Per the physician, the delivery catheter system (dcs) caused/contributed to the dissection.The lot number of the dcs was received and section d was updated.The eval method code was updated in section h6.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.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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