EDWARDS LIFESCIENCES EDWARDS CERTITUDE INTRODUCER SHEATH SET; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
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Model Number 9620IS18 |
Device Problems
Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 11/03/2020 |
Event Type
Death
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Manufacturer Narrative
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Per the instructions for use (ifu), access site complications/cardiovascular injury, including perforation of the ventricle or myocardium, bleeding, and injury at the site of ventricular access that may require repair are potential complications associated with the transapical tavr procedure.Per literature review, risk factors for apical laceration and bleeding include friable tissue, fatty apex, chronic steroid use, dilated lv with thinned walls, and hypertension during removal of the sheath.While patient characteristics are important, achieving good hemostatic control of the lv apex is one of the most critical steps in ensuring the success of the transapical procedure, particularly in the elderly with friable tissue.Additional literature review confirms there is a higher incidence of apical bleeding in female patients and patients over 80 years old.This information correlates with review of complaint history, revealing that the majority of apical bleeding complications appear to be related to surgical technique and/or diseased ventricles during the insertion or removal of the sheath.The thv training manuals note that removal of the sheath and attempted closure of the apical incision may be associated with blood loss.Rapid burst pacing can be used to lower the systemic blood pressure during sheath removal and apical closure.The thv training manuals also recommend the physician consider performing the procedure under full cpb support for certain patients, including those with cardiogenic shock (cardiac index < 2 l/min per square meter) despite volume challenge and inotropic support, profound lv, rv, or biventricular dysfunction, and notably friable apex.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigational results indicates that the cause of the apical tear while tying the purse string sutures was likely due to patient factors (advanced age and friable tissue).The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
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Event Description
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As reported by an edwards lifesciences affiliate in (b)(6), a 26 mm sapien 3 valve was successfully implanted in a non-edwards mitral surgical valve via transapical approach.When closing the apical access site, the ventricle was damaged when tying the second concentric purse string suture.Despite multiple attempts to repair the ventricle with new sutures the patient expired.Per report, post deployment, some resistance was encountered when retrieving the certitude delivery system into the sheath.However, the certitude was removed correctly.Per medical opinion, the ventricle was damaged due to the patient's myocardial wall being too fragile.
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Manufacturer Narrative
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The following fields were corrected as the device was returned: b1, d10, d11, f10, h3, and h6.The device was returned for evaluation per preliminary visual inspection of the returned devices no abnormalities observed on delivery system and sheath 'seemed accordioned in multiple places.' the product evaluation is underway.
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Manufacturer Narrative
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The 26 mm certitude delivery system was returned partially inserted through the sheath and the loader.No procedural imagery was provided by the site.Visually inspected revealed residual fluid remained in the delivery system, the sheath shaft was compressed at multiple areas, and scratches were observed on the distal tip of the sheath.Dimensional testing revealed all areas met specification.Due to the nature of the device returned condition functional testing was unable to be performed.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The instructions for use (ifu), device preparation and the training manual were reviewed for instructions or guidance for proper use of the edwards certitude sheath and no deficiencies were identified.During the manufacturing process, the certitude sheath is visually inspected and tested several times.During manufacturing, the sheath shaft component was 100% inspected.During the final inspection, the sheath underwent 100% inspection by both manufacturing and quality.Additionally, all manufacturing lots are subject to product verification (pv) testing on a sampling basis.All samples passed product verification testing for this lot number.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 edwards lifesciences risk management documentation was performed for this case. 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. the complaint for sheath, shaft compressed / crushed was confirmed upon visual inspection.No manufacturing non-conformances were identified in the returned sample.A review of lot history, complaint history, dhr, and manufacturing mitigation's supported that a manufacturing non-conformance likely did not contribute to the reported events.A review of ifu / training materials revealed no deficiencies.There was no note of abnormalities on the sheath during device preparation, suggesting that there was no issue with the device when removed from packaging.Per the complaint description, ¿resistance retrieving the certitude ds balloon into the certitude was felt.¿ the operator may have used excessive force and manipulation to overcome the observed withdrawal difficulties, which may subsequentially result in the compression and damages observe don the sheath shaft.Without the return of procedural imagery, a definitive root cause is unable to be determined.However, available information suggests that procedural factors (withdrawal difficulties of delivery system / excessive manipulation) may have contributed to the complaint events.The complaint was confirmed.No manufacturing nonconformances were identified.No labeling / ifu / training inadequacies were identified.As such, neither a product risk assessment escalation, nor corrective or preventative actions are required.
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