Product analysis: the valve remains implanted therefore no product analysis can be performed.Conclusion: without 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.
|
Medtronic received information that approximately two years, one month, and eight days following the implant of this transcatheter bioprosthetic pulmonary valve, the patient complained of reduced ability to perform physical activity.An echocardiogram performed revealed an elevated gradient of approximately 85 to 100 mmhg, and a velocity of 4.5 to 5 m/sec, indicating valve stenosis, but with normal valve function.Two years, one month and 16 days following the valve implant, a catheter intervention was performed.During the intervention, several nordmeyer grade ii stent fractures were noted.A right ventricle pressure of 112 mmhg was reported, along with a femoral artery gradient of 84 mmhg.It was reported that approximately one third of the proximal part of the valve was not covered by the pre-stents and had sternal contact.Additional pre-stenting was performed with one covered stent and one bare 45 mm cp stent on a 24 mm non-medtronic balloon.A second transcatheter bioprosthetic pulmonary valve was implanted.No additional adverse patient effects were reported.
|
Conclusion: the device remains implanted.Still photo clips related to this event were received for image review.The imaging provided confirm there are stent fracture at the proximal portion of the valve.The proximal portion of the valve appears to be distorted and bent.There is no imaging provided that confirms the pressure gradients as stated in this event report.High gradients and stenosis can be related to valve related (degeneration, thrombus, calcification, etc.) or non-valve related facto rs (lvot obstruction, patient pressures, lv dysfunction, etc.).The relationship between the reported high gradients/stenosis and stent fractures cannot be established.Based on the risk analysis, stent fractures can potentially lead to increased gradients and stenosis.However, a conclusive cause of the high gradients and stenosis cannot be determined.Per melody instructions for use (ifu), stent fractures are known phenomenon; it states that ¿prominent mechanical stresses on the outflow tract stent, such as compression between the anterior chest wall and heart, appear to be associated with an increased risk of stent fracture¿.In this case, it was reported that approximately one third of the proximal part of the valve was not covered by the pre-stents and had sternal contact.This indicates that the probable cause of the stent fracture could be due to mechanical stresses on the outflow tract stent.A review of the device history record (dhr) was performed for this valve, there were no deviation identified in manufacturing process.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.Updated 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.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.
|