Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
During the index procedure a in.Pact admiral was used to treat the left arm.Approximately 14 months post procedure patient suffered thrombosed arteriovenous graft at venous anastomosis trailing edge of stent.Dialysis clinic noted patient had a clotted access and patient had shuntagram same day.Thrombus noted to be located at venous anastomosis trailing edge of stent, same as index target lesion.Thrombectomy was performed using pharmacologic thrombolysis with heparin and alteplase in conjunction with mechanical thrombectomy via chameleon5x40 and fogarty balloon angioplasty.Performed with non-medtronic 8x100 device and dissection occurred.A viabahn stent 8x100 was placed at axillary vein and trailing edge of stent.No residual stenosis noted, and procedure deemed to be a successful thrombectomy.Patient recovered.
|