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Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Sepsis (2067)
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Event Date 09/27/2022 |
Event Type
Death
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Manufacturer Narrative
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This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is female/60 years old.The model listed in the report is a representative of the model family, as there is no specific model listed.The date of death is not available at the time of this report as there is no indication of specific serial number/patient information.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: long-term outcomes of left atrial appendage isolation using cryoballoon in persistent atrial fibrillation.Europace (2023) 25, 366¿373.Doi: 10.1093/europace/euac167 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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Event Description
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Literature was reviewed regarding left atrial appendage isolation using cryoballoon in persistent atrial fibrillation (af).The authors described patient deaths; the causes of death were stroke, sepsis, coronary artery disease, malignancy, and other unknown causes.It was noted that none of the deaths could be directly linked with the ablation procedures.There were patients who experienced access site complications such as inguinal hematoma and pseudoaneurysm and resolved without surgical intervention.There were other patients who experienced intracranial bleeding, gastrointestinal bleed (gib), mild to moderate pericardial effusion which required pericardiocentesis, transient and persistent phrenic nerve damage, left circumflex artery spasm in which all were resolved with intracoronary nitrate infusion.During the follow-up period, patients suffered ischemic strokes, transient ischemic attack (tia), one retinal artery embolism, and thrombus in the left atrial appendage was observed which resolved with intensifying or optimizing oral anticoagulant therapy.Some patients recovered from stroke with variable sequelae in motor functions.The status of the catheters and sheaths is unknown.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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