COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
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Catalog Number PRB35-07-150-120 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 01/19/2024 |
Event Type
Injury
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Event Description
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During the index procedure three protege everflex stents were used to treat the right common iliac, external iliac.1 day post procedure patient suffered severe left lower extremity critical limb threatening ischemia with tissue loss. bilateral lower extremity severe peripheral arterial disease with tissue loss of the left lower extremity.Severe left lower extremity critical limb-threatening ischemia with tissue loss.The patient underwent bilateral iliac artery stenting to facilitate above the knee amputation.Both common iliac arteries were occluded, and the patient had an occluded sfa on the left side.The foot was beyond salvage, and in addition, infected with leukocytosis.The left lower extremity digit 1 gangrene and digit 2 impending ischemia and an abi of.3 upon arrival to the hospital. patient recovered.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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