As reported by alterra clinical trial, the subject was identified with a single minor wire frame fracture on inflow portion of alterra device via fluoroscopy during 12-month visit after the implantation of the alterra prestent in pulmonic position.With no loss of structural integrity noted on the 12 month visit.Per additional information, there was no prestent fracture observed at the 6 months follow up visit ct scan.Per medical records review (1 year follow up visit cardiology office note), ''the alterra device and valve are working very well without any evidence of dysfunction''.The patient was reported to be doing well without symptoms.''there is one minor stent fracture but this is not a problem.Nyha class i''.Per the physician recommendation, the patient will be following up in 1 year with no activity restrictions.
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A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions.Added new information to h.6 component codes, type of investigation and investigation findings.The alterra prestent was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was provided from the site and revealed the following: upon review of the 1 year chest x-ray, a fracture was observed at the alterra inflow (proximal) apices.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A review of the risk management documentation was performed, and the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.An in-depth evaluation related to alterra prestent fracture has been documented in technical summary written by edwards lifesciences, the prestent in straight configurations is safe under pulsatile loads based on the finite element analysis (fea) models, accelerated wear and tear (awt) and fatigue testing.As such, the potential fracture on the proximal end of the frame could be attributed to the conditions of the patient's anatomy.Technical summary documented a review of available ct scans / imagery for patients with a fractured stent.As seen in the provided imagery, upon review of the 1 year chest x-ray, one fracture was found at the alterra prestent inflow (proximal) apices.Per the technical summary, patients who had a fracture exhibited rvot length on the shorter side compared to the population.The technical summary's imagery review also suggested that the fractures were likely to occur where the stent apices were engaged with the bend of the patient's anatomy.It is possible that this positioning resulted in some apices of the inflow side of the stent engaging with anatomy, putting strain on the stent.However, as there existed patients with similar anatomical conditions that did not have fractures, the technical summary concluded that shorter rvot length, increased curvature, and increased level of engagement do not dictate a fracture but may increase the risk of one.Additionally, technical summary reviewed the manufacturing documentation and conducted a sem (scanning electron microscope) micro crack study to determine if microcracks could be present on the frame prior to implantation of the pre-stent.No microcracks were observed on the frames at any phase of the investigation and no evidence of a manufacturing non-conformance that could have contributed to the complaint event was found.While a definitive root cause is unable to be determined, available information suggests that patient factors may have contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.
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