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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stenosis (2263)
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Event Date 03/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During the index procedure one medtronic standard pta balloon was used to treat the venous outflow of the right arm.Approximately 9 months post index procedure the patient suffered shunt stenosis.This was treated with medication and a non medtronic pta to treat the anastomosis.The event is resolved.The investigator and safety reported that the event is not related to the index device, procedure or paclitaxel.Cec adjudicated event is not related to procedure or therapy but related to device.The revascularization procedure was adjudicated as a clinically driven target lesion revasc.
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Manufacturer Narrative
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Patient medical history is hypertension, hyperlipidemia, diabetes, renal insufficiency coronary heart disease and previous peripheral revascularization of the anastomosis.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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