EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
|
Back to Search Results |
|
Model Number 11500A |
Device Problem
Perivalvular Leak (1457)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/13/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
|
|
Event Description
|
It was learned through implant patient registry and investigation that a patient with a 27mm 11500a aortic valve was explanted at implant due to regurgitant jet/pvl through the valve.The explanted valve was replaced with a 25mm 11500a valve.Per medical records, the patient underwent an avr.Intraoperatively there was native aortic valve and annular calcifications which was debrided, the large annulus was sized to 27mm.A 27mm 11500a was implanted with total of 14 sutures, valve was seated and secured with cor-knots.The patient was weaned from bypass and cannulas removed.Tee showed regurgitant jet through the valve that was at least mild-moderate and eccentric.Decision was made to evaluate the valve and the patient was recannulated.The valve was found to have no obvious defect, however there was an area under the right cusp where a shaft of calcium was not well seated and possible source of perivalvular leak.The valve was replaced with a 25mm 11500a.Post tee showed good valve function with no regurgitation and gradient of 8mmhg.The patient was transferred in critical, but stable condition to the icu.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.
|
|
Manufacturer Narrative
|
Updated sections: d4 expiration date, g3, g6, h4, h6 component code, type of investigation, investigation findings, and investigation conclusions.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed to the event.
|
|
Search Alerts/Recalls
|
|
|