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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Foreign Body Reaction (1868); Granuloma (1876); Local Reaction (2035)
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Event Type
Injury
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Manufacturer Narrative
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Abstract titled 'rare adverse event following cyanoacrylate closure of greater saphenous vein'.Vascular medicine 27(6) poster number: 60 abstract number: 1265519.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received an abstract titled 'rare adverse event following cyanoacrylate closure of greater saphenous vein'.The article reports the case of an exaggerated immune response to cyanoacrylate glue leading to destruction of vein wall, development of foreign body granulomas around extruded glue and fistulas with extrusion of glue to the exterior.Treatment ultimately required complete resection of the foreign object.A patient with non-healing mixed arterial and venous ulcer underwent treatment of venous reflux in the right great saphenous vein (gsv) with cyanoacrylate glue using venaseal closure system.His wounds healed completely, however, 2 months later he developed a lump in the medial knee with increased leg swelling.He also developed fistulas along the medial aspect of his leg with extrusion of thick viscous material.Ultrasound showed irregular cystic tissue suspicious for foreign body granuloma along the medial aspect of the knee and lower leg.He was treated with intra-lesional and systemic steroids.This resulted in significant improvement however, the wounds worsened after completion of the prolonged steroid taper.He did not develop fever, chills or leukocytosis during this time period.Empiric antibiotics did not have any significant clinical effect on the granuloma formation.Eventually, excision of the below knee gsv and complete excision of the right groin mass was performed.Histopathology showed granulomatous lesions.Groin granuloma included pellets that likely represented extruded glue casts with no growth in cultures.All wounds healed however, a few weeks l ater, he developed a new lesion in the distal thigh where there was residual cyanoacrylate.He subsequently underwent excision of remainder of gsv with complete resolution of his symptoms.
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Search Alerts/Recalls
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