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Source: de-identified and unpublished study data on mosaic bioprosthetic surgical heart valves from london health sciences centre, ontario, canada.Initial start of study used for date of event.Patient age, gender, or weight cannot be provided due to regional privacy regulations.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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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Medtronic received information from unpublished study data on clinical outcomes for patients implanted with the mosaic bioprosthetic surgical heart valve.All data were collected retrospectively and actively at a single canadian center between 2014 to mid-2020 when the study was abandoned due to lack of staffing resources.The incomplete study data was not summarized or published by the center but was later provided to medtronic clinicals for review.All 633 patients enrolled in the study were implanted with a medtronic bioprosthetic heart valve in the atrial or mitral position.The study data was de-identified and contained no unique device or patient identifier numbers.Among all patients a total of 60 deaths occurred.For 59 of those patient deaths there was no statement of causal or contributory re lationship between medtronic product and the death.During the implant of a medtronic 21-mm mosaic aortic bioprosthetic valve, patient number 10 developed hemodynamic and electrical instability due to an intramural thrombus located in the circumflex artery.The t hrombus was successfully removed, and coronary grafts were placed.Following the procedure, the patient continued to be supported by extracorporeal membrane oxygenation (ecmo) and remained in the intensive care unit (icu) with noted coagulopathy and acute renal f ailure.At one day post-implant, due to continued bleeding from the surgical wound site, the patient underwent intervention where surgical glue was applied to suture needle holes at the wound site.Following this procedure, while on full ecmo and intra-aortic balloon pump support, the patient had poor peripheral profusion followed by severe bradycardia and later asystole.Despite maximum resuscitative efforts the patient died of cardiorespiratory failure and cardiogenic shock one day post-index procedure.Based on the available information medtronic product or the implant procedure was associated with the death.Among all patients adverse events included: severe aortic regurgitation, severe mitral regurgitation, severe paravalvular leak, stroke, thromboembolism, atrial fibrillation, non-st segment elevation myocardial infarction (nstemi), pulmonary embolism, pleural effusion, cardiogenic/septic shock, structural valve dysfunction, valvular stenosis, high gradients, endocarditis with vegetation and/or thickening of aortic leaflets, cardiac tamponade, aortic dissection, hypertension, sternal wound dehiscence, sternal wound infection, major bleeding event or hematoma requiring intervention, syncope, arrhythmia requiring permanent pacemaker implant, congestive heart failure, valve leaflet perforation and/or tear, and reoperation to explant or replace the bioprosthetic valve.Based on the available information medtronic product was associated with these clinical observations.No additional adverse patient effects or product performance issues were reported.
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