Model Number PVS25 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Complete Heart Block (2627)
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Event Date 12/12/2013 |
Event Type
Injury
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Manufacturer Narrative
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As the device remains implanted in the patient, a full analysis of the prosthesis cannot be performed.A complete manufacturing and quality records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Further investigation is ongoing.Device not explanted.
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Event Description
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The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2013, a (b)(6) years old female patient received a pvs25 to replace the native stenotic aortic valve.The procedure was performed through mini-sternotomy and no concomitant procedures were performed.On (b)(6) 2013, the patient received a pacemaker due to an av block grade iii.The valve functionality was observed on (b)(6) 2013 (mean gradient of 24mmhg and no leaks) and on (b)(6) 2015 (mean gradient of 12mmhg, no leaks).The patient underwent surgery in sinus rhythm w left bundle branch block (lbbb).
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Manufacturer Narrative
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Based on the information available, it is not possible to establish the exact root cause of the event.However, based on the preoperative information reported in the sure avr registry, the patient underwent surgery in sinus rhythm with lbbb, and some studies have shown that lbbb is predictive of avb iii post savr (surgical aortic valve replacement).Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease and preoperative aortic regurgitation.This event is, therefore, a known, inherent risk of the procedure.
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Event Description
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The manufacturer was informed on this event through the sure avr registry.On (b)(6) 2013, a 66 years old female patient received a pvs25 to replace the native stenotic aortic valve.The procedure was performed through mini-sternotomy and no concomitant procedures were performed.On 12 dec 2013, the patient received a pacemaker due to an av block of grade iii.The valve functionality was observed on 13 dec 2013 (mean gradient of 24mmhg and no leaks) and on 24 apr 2015 (mean gradient of 12mmhg, no leaks).The patient underwent surgery in sinus rhythm w left bundle branch block (lbbb).The following additional information was received by the site: the patient had no rhythm disturbance pre-operatively, so there is a high probability that the block is related to the implant of the prosthesis; it was emphasized, however, that the surgical prostheses are correlated with an incidence of postoperative av block; moreover, the incidence is not related only to the type of prosthesis, but above all to the accuracy of the decalcification of the aortic ring near the conduction bundle; a further variable is given by the degree of oversizing of the prosthesis, whose radial force (like the self-expandable trans-catheter prosthesis) could be the basis of the aforementioned block.
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Search Alerts/Recalls
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