Catalog Number A35HPV06040040 |
Device Problems
Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stenosis (2263); Patient Problem/Medical Problem (2688)
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Event Date 09/26/2018 |
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 ((b)(6) 2017) the left venous outflow was treated with fortex balloon catheter and an in.Pact admiral balloon catheter.Approximately 4 months post index procedure ((b)(6) 2018), the patient suffered shunt stenosis.The patient was treated with medication and pta of the venous outflow ((b)(6) 2018).The patient is reported to have recovered well.
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Manufacturer Narrative
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During the index procedure one fortrex standard pta was used with an admiral xtreme, 4 months post index procedure a fortrex balloon and an admiral xtreme used.Update (b)(6) 2018: approximately 6 months post index procedure ((b)(6) 2018), the patient suffered shunt stenosis.This was treated with medication and pta of the venous outflow ((b)(6) 2018).The patient recovered.Update (b)(6) 2018: approximately 9 months post index procedure ((b)(6) 2018), the patient suffered avf shunt stenosis.The patient was treated with medication and target vessel revascularisation using a non-medtronic device ((b)(6) 2018).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Updated information: approximately 11.5 months post index procedure the patient suffered avf shunt stenosis.The patient was treated with medication and target vessel revascularisation using a non-medtronic device on (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Approximately 14 months post index procedure and 10 months post revascularisation procedure, avf shunt stenosis was reported.The patient was treated with medication and revascularization of venous outflow was carried out using a non-mdt pta.Approximately 18 months post index procedure and 14 months post revascularisation procedure the patient suffered avf shunt stenosis and was treated with medication and pta of the venous outflow approximately 21.5 months post index procedure and 16.5 months post revascularisation procedure, the patient suffered avf shunt stenosis and was treated with medication and pta of the venous outflow.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The cec adjudicated the revascularisation as target lesion, clinically driven and related to the device but not related to the procedure or paclitaxel.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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