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Model Number 8300AB |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Arrhythmia (1721); Complete Heart Block (2627)
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Event Date 07/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Peri-procedural arrhythmias, heart block, and other conduction disturbances are common in patients with underlying cardiovascular disease and/or conduction abnormalities.They can be exacerbated with standard perioperative medications, anesthesia, and/or instrumentation of the heart.Temporary pacemakers are inserted in all patients undergoing aortic valve replacement (avr).It is not uncommon for patients to have short term/reversible periods of heart block or arrhythmias following the procedure while their heart recovers from cardiopulmonary bypass.In many cases, the temporary pm is left in the patient for a short time following the procedure and then subsequently removed prior to discharge.Following surgical aortic valve replacement (avr), new-onset bundle branch block has been reported in 16% to 32% of patients and the need for permanent pacemakers in 3% to 8% of patients.The reason for post-operative av block after surgical avr is related to injury to the cardiac conduction system during surgical excision of the adjacent diseased valve and annular tissue.The close anatomical relationship between the aortic valvular complex and the branching atrioventricular bundle explains the possible development of conduction abnormalities following prosthetic aortic valve procedures.In this case, the root cause of this event cannot be conclusively determined.However, there has been no indication or allegation that the edwards device caused or contributed to this event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.
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Event Description
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Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.In this case, it was reported that the patient underwent aortic valve replacement with the subject device.Mitral valve replacement was also performed.The patient tolerated the procedure well and was taken to intensive care in stable condition.The patient developed av block and received a permanent pacemaker on pod #6.The patient was discharged on pod #7.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Search Alerts/Recalls
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