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"prosthetic valve leaflet perforation is one of the complications after manual suturing techniques.Repetitive trauma from suture tail is proposed to be the mechanism behind prosthetic leaflet perforation, and hence sutures must be cut close to the knots.7 although valve perforation has been reported with manual suturing techniques, only a few cases have been reported in the literature with cor-knot device use." the authors also note in the conclusion section, "automatic fastener devices have facilitated cardiac surgery by reducing aortic cross-clamp time and cardiopulmonary bypass time.Regardless, extreme caution and meticulous surgical techniques are essential to prevent complications such as valve perforation or damage and valve dysfunction and subsequent redo surgery.Medial orientation of cor-knot sutures must be avoided." we believe this report recently found in the literature presents another unfortunate patient with cardiac valve perforations associated with improper use of cor-knot® titanium fasteners.As the authors conclude, and we concur, "medial orientation of cor-knot sutures must be avoided" to minimize the known risk of erosion and perforation of adjacent leaflets from repeated contact with a foreign material, such as trimmed suture tails or a metal fastener.This case report demonstrates an extremely inappropriate surgical technique without any indication that the cor-knot® device or cor-knot® titanium fastener failed to perform or function as designed.In this patient's first operation, appropriate surgical technique and judgement were not used; the damage to the first valve and the need for the second operation were completely avoidable.In this patient's first operation, not only do the titanium fasteners in question appear oriented in the wrong direction (medially) directly towards the adjacent leaflet, they also appear located not even on the prosthetic sewing-cuff as is intended in this valve's design.Rather, the initial surgeon placed the sutures away from the sewing-cuff area and into the prosthetic's covered frame, which is much closer to the leaflets.Please see lsi's filed medwatch manufacturer report #: 1320468-2018-00004 for more details and a summary of the previous known similar nine cases.These previous events were also all technique errors, not technology errors.Like the previous events, this "exceedingly rare" adverse event appears to involve a suture placement order, not any titanium fastener issue.The patient of this report, like all others known to us, successfully received a new valve in a second operation without any reported complications.This latest incident appears very similar to the first report from february 2014 (maude adverse event report number 2015691-2014-00314) ever received by lsi regarding a situation requiring repeat operation for prosthetic leaflet perforation associated with our knot replacement technology.In that first report, the surgeon also placed the prosthetic securing sutures not in the sewing-cuff, but into the covered frame of a carpentier-edwards perimount magna ease prosthesis as in this current report.To be concise, we include fig.A showing an illustration, figure 9, from the attached case report.Its caption states "intraoperative magnified image of prosthetic aortic valve with perforated defect and titanium clips (yellow arrow) placed using automated suture device, which damaged the prosthetic leaflet." these yellow arrows point to titanium fasteners pointed medially directly at the closed prosthetic leaflet which must move out laterally to open and enable blood flow in a beating heart.The inappropriately placed sutures with titanium fasteners are pointing directly medially at the closed valve with no space between the cut suture tails and their fasteners, upon which the leaflet will directly impact while opening during systole.Also note, as seen in figure 9, the titanium fasteners appear to be attached to the inside of the covered stent frame and not out radially more towards the edge of the prosthesis on the sewing-cuff where they are intended per the manufacturer's instructions for appropriate placement within this valve.With this recent additional case, we now know of ten patients who required reoperation to replace leaking cardiac valves that were damaged by malpositioning of titanium fasteners and their suture tails during cardiac surgery.The first two patients reported became known to us via the operating surgeons.Six prior other patients became known to us through surgical literature searches and were subsequently also included in the previous medwatch response which addressed a patient reported by an operating surgeon.This current medwatch reports on the seventh patient discovered through our continuous surveillance of surgical literature; this patient is the tenth patient of this series.Our company will continue to provide medwatch reports on specific patients, if any become known to us, and will continue to include literature updates in any new related medwatch submissions unless otherwise advised by the fda.We plan to continue to diligently educate our representatives who work with surgeons and operating teams to further increase awareness of this very rare, but significant avoidable risk caused by applying inappropriate technique during the use of this otherwise remarkably reliable suture fastening product.Table 1 below illustrates the total number of cardiac surgery operations using titanium fasteners to date has now reached over 487,000 cases.Now with ten reported events, the percent rate of perforations reported per cardiac surgery case is 0.0021%.By comparison, the surgical literature reports that the paravalvular leak rate is at least approximately 2 to 4% without the use of cor-knot® for aortic valve replacements.Compared to this avoidable problem caused by inappropriate suturing and product misuse as reported in the present case report, common paravalvular leaks are about 950 times more prevalent in this patient population.Table 1 worldwide total number of cor-knot® titanium fasteners cases in cardiac surgery: >487,000 reported leaflet perforations cases: 10 rate of perforations reported per cardiac surgery case: 0.0021% (relative to an ~ 2% paravalvular leak (pvl) rate: 2% ÷ 0.0020% = ~1,000x less) we are also encouraged to note that the cor-knot® product has helped so many more patients since our last related medwatch report about 2 years ago, the current rate of 0.0021% of this avoidable adverse event is now about 70% of the 0.0029% level as described in the previous medwatch report on this subject.
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A "case report" article in press, "a rare etiology for bioprosthetic aortic valve regurgitation," was found on august 3, 2020 through our company's routine surveillance of related literature.This paper reports that sometime within 3 years after undergoing an aortic valve replacement involving a 29-mm edwards stented bioprosthetic valve for aortic stenosis, a (b)(6)-year-old man presented with shortness of breath upon exertion and leg swelling.He denied any fever or chest pain.An early diastolic murmur was detected.Transthoracic and transesophageal echocardiography demonstrated a holodiastolic flow through the prosthetic valve.The authors do not report whether the surgeon providing the reoperation was the same surgeon who performed the primary operation.The patient was returned to the operating room and found to have three punctate defects in a prosthetic valve leaflet with no evidence of paravalvular leak.These leaflet defects corresponded to a location across from cor-knot® titanium fasteners placed at the time of the initial replacement surgery.The paper notes "these cor-knot sutures had been oriented medially toward the valve, resulting in valve impingement and trauma." the initial valve was explanted.A 27-mm edwards stented bioprosthesis was placed.While this report makes no mention of the patient's postoperative recovery, complications are typically reported, whereas an uneventful postoperative course often does not draw comment.
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