It was initially reported to intervascular that: "the clinic reported four cases of ischemic stroke (multiple embolization) to the distributor of our products after a brachiocephalic artery replacement (subclavian artery, left internal carotid artery and brachiocephalic trunk) with intergard prostheses.Thus, all four patients were used all three types of prostheses, 10 cm each: ref (b)(4).Operations were performed under cardiopulmonary bypass with high heparinization and flow through the prosthesis.All patients are alive and are currently in icu.They started working with intergard prostheses from the end of (b)(6) 2022.Previously, vascutec prostheses were used for this type of prosthetics (20 patients, while using ready-made multi-branch prostheses), there were no complications.Strokes were diagnosed the next day after surgery.All four cases in october (age, sex, dates of operations could not be named).Operating surgeons are different.After a series of complications, it was decided to conduct an experiment with an in-vitro prosthesis.They opened a new package, soaked in a solution of rifampicin, saw an uneven coating of collagen, with a maximum accumulation of collagen in the folds of the prosthesis.When impregnating the prosthesis in blood with heparin, the formation of blood clots on the prosthesis was detected.Sectional photo in attachment." after a meeting held on 11-nov-2022 between the medical affairs manager, russia sales and service unit and complaints team members involved with this complaint, the following additional information regarding the reported events was provided: -there are 2 confirmed cases of patient stroke where an intergard graft was implanted (a third case of stroke exists, however, the team cannot confirm that an intergard graft was implanted in this patient) -both cases were complicated aortic procedures utilizing intergard grafts as well as other prosthetic grafts (such as medtronic stent graft and bbraun unigraft) -a hand drawn image has been provided showing where grafts were implanted, however, it does not include labels of the products used ¿ a separate, labeled drawing for each patient¿s procedure has been requested.The following additional information regarding the reported events was provided by the hospital on (b)(6) 2022: regarding the surgery: "supracoronary prosthesis of the ascending aorta, arch and its branches (multi branch prosthesis).Endoprosthetics of the thoracic aorta with a medeng n30 hybrid stent graft according to the "frozen elephant trunk" technique with cpb.Operation date: (b)(6) 2022." after surgery, it was reported that "in the postoperative period after awaking, the patient has right sided hemiparesis.According to mri data (b)(6) 2022), ischemic stroke in the left carotid basin (parietal, frontal lobe on the left)." the list of concomitant medical products is the following: ¿bbraun uni-graft k dv ø 12 1104128 , bbraun ø 10 1102109 , vascutec ø 8 736008 , onduit medeng ref st.28-esv.25-f.1.1 (includes vascutec 28mm), device medeng name "surgical stent graft for the descending thoracic aorta " (ref n/a) and glue bioglu bg 3502-5-.¿ in addition, information was obtained that only two patients with one intergard graft each were involved in the event.An separate medical device reporting (mdr) will be submitted for the second patient.
|
(11/213) for the investigation of the two cases of stroke reported simultaneously: complaint #(b)(4) (mfr report #1640201 2022 00034) and complaint #(b)(4) (mfr report #1640201 2022 00035), one retention sample from the same sterilization lot number and with the same fabric type as the involved devices was selected.This retention sample was coated on the same day and with the same coating parameters as the product involved in the complaint #(b)(4) (mfr report # 1640201 2022 00035).The retention sample was returned to an external and independent laboratory for examination.Macroscopic and microscopic analyses were performed, they concluded that the retention sample does not present any degradations of the textile structure.There is a collagen coating but its white coloration does not allow to visualize it.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
|