Product analysis: the valve was not returned, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, a deformation of valve frame cells was noted during the loading process after encapsulating the paddles and cells of the valve outflow crown.It was reported that some cells at the level of the valve waist did not have the canonic diamond shape but were deformed.The back plate and tip guide tube had not yet been removed.The valve was released with the use of sterile water at room temperature.The valve expanded but some cells remained deformed.When gentle manipulation was used at the side of one of the damaged cells in an attempt to bring it back to the diamond shape, it broke apart.Subsequently, the valve was not used.The procedure was completed using a different valve that was loaded into the same delivery system with the same loading system.The loading was performed by hospital staff that was attending loading certification (15 loadings joined) and experienced medtronic personnel.No adverse patient effects were reported.
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Product analysis: upon receipt at medtronic¿s quality laboratory, the device was in its original container, submerged in clear solution.The frame was distorted with an oval-shaped outflow appearance.All leaflets were pliable and intact.All leaflets were in the closed position with a gap at the point of coaptation.All commissures were intact.The frame exhibited signs of distortion with multiple bent struts lateral to the c paddle.One broken strut was observed.The damage on the frame was suggestive of frame misalignment during the loading process.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Analysis of the returned valve was able to identify signs of distortion with multiple bent struts lateral to the c paddle.One broken strut was also observed.The engineer review concluded that the valve frame experienced one fracture in valve housing section in conjunction with permanently deformed cells indicative of misloading.The concluded root cause is misloading.Loading of the valve is a process that is highly dependent on the operator technique; in this case, the inspection process per the i nstructions for use (ifu) was performed and properly identified the bent crowns / fracture on the valve, prior to introduction to the patient.It should also be noted that per best practices training, the temperature of the loading bath should be between 0-8 degrees celcius.Bath temperatures not sufficiently chilled can lead to excess loading forces.In addition, proper lighting should always be used to visually confirm paddles are properly seated and all outflow crowns are captured within the capsule.While nitinol is a material which features ¿shape memory¿ and ¿super-elastic¿ material properties, extreme levels of strain/deformation beyond the elastic properties of the materials result in permanent/plastic deformation which is not reversed by warming the material.This effect is amplified if the loading process/deformation is not performed while the material is at sufficiently low temperatures.Permanent deformation of the valve¿s nitinol frame can result from subjecting the device to extreme deformation conditions, such as those occurring during severe misloads of the valve into the compression loading system (cls) or the delivery catheter system (dcs).This event took place prior to introduction of the patient, and no adverse patient effects were reported.Updated data: method, results, and conclusion codes.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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