Model Number ENS1022 |
Device Problems
Material Puncture/Hole (1504); Malposition of Device (2616); Device Dislodged or Dislocated (2923)
|
Patient Problem
Pulmonary Valve Insufficiency/ Regurgitation (4452)
|
Event Date 07/12/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: other relevant device(s) are: product id: pb1018, serial/lot #: (b)(4), ubd: 27-aug-2021, udi#: (b)(4).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.
|
|
Event Description
|
Medtronic received information that during the implant of this transcatheter bioprosthetic pulmonary valve, the delivery catheter sy stem (dcs) balloon was punctured, resulting in the release of the valve into an inadequate position.The valve dislodged above the native pulmonary valve causing unspecified insufficiency.A second transcatheter bioprosthetic pulmonary valve was implanted.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Additional information was received that it was the inner balloon that was punctured.Following the dislodge, the insufficiency was severe as the valve did not remain in the outflow tract.No additional adverse patient effects were reported.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.
|
|
Manufacturer Narrative
|
Additional information was received that the when the inner balloon was inflated, solution had leaked into the external balloon, cause the valve to be released incorrectly.The pressure used for release was not reported.It was reported that the patient had an existing surgical aortic valve in place, with no major calcification reported.No additional adverse patient effects were reported.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.
|
|
Manufacturer Narrative
|
Additional information was received that the balloon perforation was not identified until inflation during implant but was suspected to be present prior to attempting implantation.It was unknown what caused the inner balloon to break.The perforation generated an inadequate opening of the valve which resulted in implantation in the incorrect location.The perforation caused the solution to leak into the external balloon.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.
|
|
Manufacturer Narrative
|
Additional information was received that there was no relationship between the previously implanted surgical valve as the fracture was in the internal balloon.No additional adverse patient effects were reported.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.
|
|
Manufacturer Narrative
|
Conclusion: a review of the device history records was performed for this valve and delivery catheter system.There was no deviation identified in the manufacturing processes.The devices were manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.The manufacturer assessment / review for the delivery catheter system stated that a process monitoring sample from this lot was tested before the lot was shipped.The inner balloon burst at 10 atm.The outer balloon burst at 6 atm.Both pressures are well above the labeled rated burst pressures.In this case, the exact pressure at the time of the rupture was unknown.As designed, the outer balloon fully contains the inner balloon so that the delivery system was still usable when inner balloon failed.There have been no other similar complaints associated with this lot number.Image files were received for review.However, the images provided were not sufficient to evaluate the cause of the inner balloon rupture.Valve dislodgements are typically not related to a device malfunction.Inaccurate positioning the valve and inaccurate delivery through patient anatomy is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuosity, etc.).Based on the investigation, manufacturer assessment, image review, and available information, the cause of the rupture of the inner balloon cannot be determined.However, there is no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to this event.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.
|
|
Search Alerts/Recalls
|
|