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INTERVASCULAR SAS INTERGARD WOVEN STRAIGHT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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| Model Number IGW0010-30 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Quadriplegia (2449); Syncope/Fainting (4411); Ischemia Stroke (4418)
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| Event Date 10/24/2022 |
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Event Type
Injury
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Event Description
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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 igw0012-30, ref igw0010-30, igw0008-30.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 on (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.According to unconfirmed information, prostheses from different manufacturers could be used during the operation." 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 with a vascular prosthesis "basex-sp" no.28, the aortic arch and its branches with a multi-branched prosthesis.Prosthetics of the aortic valve with a biological prosthesis "medtronic hancock" no.23.Cabg (2 mammary-coronary bypasses - anterior descending artery, posterolateral branch (i-graft from the left internal mammary artery) with cpb.Operation date: on (b)(6) 2022." after surgery, it was reported that "ischemic cryptogenic stroke in the left carotid basin (in the frontal lobe), in the right carotid basin with slight hemorrhagic impregnation (in the frontal lobe).Tetraparesis to plegia in the right limbs and left leg.Convulsive syndrome in the early postoperative period.Cochleovestibular syndrome on the left.Meniere's disease? bca atherosclerosis.According to the nihss scale 28 points.Rankin 5.Rivermead mobility index 0." the list of concomitant medical products is the following: ¿bbraun uni-graft k dv ø 12 1104128, bbraun ø 10 1102109, bbraun ø 8 (ref n/a), sp ø 28 (the article number is not known, it was in a single copy, the box was thrown away).Russian-made prosthesis of blood vessels intended for surgical treatment of lesions of the aorta, its branches and other arteries.Corrugated vascular prosthesis: woven base of fluorolone, polyester threads and modifying nanoscale, biodegradable, multilayer coatings (textile base of foreign production) ; valved conduit medtronic hancock #23 (aortic valve) and glue bioglu bg 3502-5-g." in addition, information was obtained that only two patients with one intergard graft each were involved in the event.A separate medical device reporting (mdr) will be submitted for the second patient.
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Manufacturer Narrative
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Device is not accessible for testing as it remained implanted in the patient.The review of historical data indicated that no other complaint was reported for the same sterilization lot number.The device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.The actual device involved in the adverse event remained implanted.
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Event Description
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Complaint #(b)(4).
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Manufacturer Narrative
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(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 #715958 (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.
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Event Description
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Complaint #(b)(4).
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Manufacturer Narrative
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(4102/213) biological testing have been commissioned to an external and independent laboratory (namsa) for the two complaints #(b)(4)and #(b)(4) (mfr report # 1640201 2022 00034).The test results lead to the following conclusions: "the customer reported two cases of ischemic stroke.Stroke can be induced by a thrombogenic device.To evaluate the thrombogenicity of the retention device, two complementary biological assays were subcontracted to namsa: partial thromboplastin time assay, according to iso 10993-4:2017 and astm f2382-18: platelets and leucocyte count assay, according to iso 10993-4:2017 and astm f2888-19 biological testing was undertaken on a retention product to evaluate whether these complaints could be associated with a thrombogenic product.Hemocompatibility tests (ptt and p&l) were performed as per astm test methods.Ptt met the acceptance criteria and p&l reached inconclusive results.Additional testing was undertaken and no significant difference was identified between the retention product and comparison articles from the finished goods inventory.These results support that the observed effects in the complaints are not caused by product thrombogenicity." (11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
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Event Description
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Complaint# (b)(4).
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Manufacturer Narrative
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Corrected data: on block h10, the conclusion of the historical data review was updated to : ((b)(4)) the review of historical data indicated there are two similar complaints of stroke (including the present one complaint #(b)(4) - mfg report number 1240201 2022 0035 and complaint #(b)(4) - mfg report number 1240201 2022 0034) reported for the same sterilization lot number 22d28.Specifically, they were reported simultaneously, by the same surgical team.Two different patients were involved.It should be noted that that the two events took place a few days apart in the same medical center with the same surgical team.There was only one investigation for both events, therefore they share the same conclusion.Additional manufacturer narrative: (4112/213) the case and the associated complaint #(b)(4) and their investigation have been reviewed by the medical affairs department whose assessment is below: "complaints #(b)(4) (mfg report number 1240201-2022-0034) and #715958 (mfg report number 1240201-2022-0035) refer to cases of stroke reported from the center of cardiovascular surgery in penza, russia.These patients were operated in late october 2022 for ascending aortic aneurysms.Complaint #(b)(4) (mfg report number 1240201-2022-0034) refers to a 73-year-old man with the diagnosis of multifocal atherosclerosis of the aorta, a saccular aneurysm of the aortic arch, a small aneurysm of the infrarenal aorta, and ischemic heart disease.The patient previously underwent a percutaneous transluminal coronary angioplasty and stent placement of the right coronary artery and the anterior descending artery in june of 2022; presents with generalized atherosclerosis, hypertension, and has a history of an ischemic stroke from 2004.On (b)(6) 2022, the patient underwent an ascending aortic arch replacement and debranching, utilizing the frozen elephant trunk technique under cardiopulmonary bypass.An intergard woven 8mm x 30cm vascular graft was implanted to replace the left common carotid artery, as well as a variety of surgical devices from other companies (listed above).The patient was reported to have had a stroke of the left carotid basin the day after his surgery that was classified as rankin level 5.Complaint #(b)(4) (mfg report number 1240201-2022-0035) refers to a 60-year-old woman that presented with an aneurysm of the ascending aorta and the aortic arch, degenerative valve disease, and ischemic heart disease.The patient underwent a percutaneous angioplasty and stenting of her right coronary artery on (b)(6) 2022.The patient also presents with pulmonary hypertension, chronic heart failure, hypertension, and type ii diabetes.On (b)(6) 2022, the patient underwent an ascending aortic arch replacement and debranching, utilizing the frozen elephant trunk technique under cardiopulmonary bypass.An intergard woven 10mm x 30cm vascular graft was utilized to replace the left common carotid artery; other devices from different companies were also used (listed above).The patient was reported to have had a stroke of the left carotid basin the day after surgery that was classified as rankin level 5.There was a third case of early postoperative stroke initially reported, but no further information was provided as the surgeons could not be sure if a getinge graft was implanted or not during this procedure.The surgeons are well versed in these procedures and perform them regularly.The devices used at this site were traditionally manufactured by vascutek; the use of getinge grafts had only recently started when these complications occurred.An experiment was performed in vitro by the surgeons to determine of the grafts were thrombogenic.New unused devices were opened and used for this purpose (the actual grafts used were not detailed in the report).The grafts were first soaked in rifampicin.An uneven coating of collagen was noted by the surgeon, especially in the folds; heparinized blood was used to soak the graft(s) and blood clots formed on the surface.Photos were provided showing small blood clots adhered to the folds of the graft.A protocol of the study was not provided.Device history records were reviewed and did not show any nonconformance; historical data and trend analysis reviewed showing no complaints from this sterilization lot; there is no history of stroke from this product family (intergard woven graft).Water permeability records were reviewed and shown to be within specifications.Macro and microscopic analysis of a representative retention sample was performed at an independent laboratory, geprovas (strasbourg, france) and did not present with any degradation of the textile structure.Additional biological testing was performed at namsa (minneapolis, mn) on retention samples from the finished goods inventory to evaluate potential thrombogenicity.Two separate biological assays were undertaken: ptt (partial thromboplastin time) and a p&l (platelets and leucocytes count).The first, ptt, met the criteria; the second, p&l, was inconclusive but did not show a significant difference between the retention sample and the six comparison articles.Medical affairs met with deputy chief dr.(b)(6), and the quality team on (b)(6) 2023.The case was presented by dr.Tungusov, as well as the experiment that was performed.Dr.Manson presented the steps taken and the results of the investigation performed by the quality team.A future call was discussed between dr.(b)(6) and the corporate medical officer at a date to yet be determined.A definitive conclusion is not possible as the grafts remain implanted in the patients.(4315) based on the analysis of the investigation findings and the medical review, no conclusion can be drawn on the exact origin of the adverse event since the involved product remained implanted.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.(22) it should be noted that as per instruction for use, section "undesirable side-effects", stroke is a undesirable side-effect.
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