MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 995 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Hemorrhage/Bleeding (1888)
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Event Date 03/13/2021 |
Event Type
Injury
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Manufacturer Narrative
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Citation: sekgololo et al.Bailed out by tevar in a horrendous bleeding aortic arch cannulation site.Int j surg case rep.2021 apr; 81: 105768.Published online 2021 mar 13.Doi: 10.1016/j.Ijscr.2021.105768.Earliest date of publication used for date of event.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.
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Event Description
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Medtronic received information via literature regarding a 72-year-old female patient who presented with chest pain, tachycardia, and cardiomegaly. a transthoracic echocardiogram showed dissection of an ascending aneurysm resulting in severe aortic regurgitation (ar). the patient underwent surgery via median sternotomy in which a medtronic 33-mm freestyle stentless valve used to replace the native aortic root and was subsequently anastomosed to a dacron tube graft to create the hemi-arch. the immediate post-operative results were satisfactory; however, the patient continued to bleed from the arch cannulation site. two days following implant a computed tomography angiogram confirmed bleeding from a mediastinal hematoma. in a repeat surgery, a thoracic endovascular aortic repair (tevar) stent was implanted which resolved the bleeding. post-tevar recovery was uneventful, and the patient was discharged home in stable condition eight days later. at one-month follow-up the patient was noted to be in good condition. no additional adverse patient effects or product performance issues were reported.
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