Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Reocclusion (1985)
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Event Date 10/29/2015 |
Event Type
Injury
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Manufacturer Narrative
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A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.(b)(4).
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Event Description
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The patient was enrolled in (b)(6) 2013.The index procedure was successfully performed with 3 drug eluting balloons on (b)(6) 2013.The target lesion was lesion l-1 in the middle sfa, distal sfa, and popliteal segments 1, 2, <(>&<)> 3.The stenosis was 100% (total occlusion) and the lesion length was 260mm.The index procedure was performed on the left leg in-stent restenosis (unknown model and date of implant).Pre-dilation was performed successfully with a 4x80 and 4x200mm balloons.(b)(6) 2014 the patient underwent target lesion revascularization (tlr) to the target lesion (l-1).The lesion was totally occluded, 210mm in length.A 5x200mm powercross balloon was used and a 4x80 pacific used.No deb or stenting was required post dilatation.The total treated lesion length was 250mm.On (b)(6) 2014 the patient returned and underwent tlr/tvr (revascularization) to the target lesion l-1 again.Diameter was 100% stenosis (total occlusion), and the lesion length 280mm.The restenosed length was 100mm.The occluded lesion length is 180mm.Symptoms present and the abi had dropped greater than 20%.A 5x200mm evercross was used to treat.No deb or stenting was needed.The total treated length is 300mm.On (b)(6) 2015 the patient again underwent tlr/tvr to the target lesion l-1.There was 100% stenosis (total occlusion).The patient was treated with 3x220 and 4x80 (non-covidien/medtronic) balloons and finally a 5x200mm powercross.No deb or stenting was required.
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Manufacturer Narrative
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This is a correction to the initial mdr with date of this report 09-nov-2015.The initial mdr incorrectly stated "a review of the manufacturing records for this device did not reveal any discrepancies relevant to the reported event".A review of the manufacturing records was not performed due to a lot number not being received from the user facility.
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Manufacturer Narrative
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Additional information received: it is reported that approximately 16 months post use of the previously reported powercross balloon, 22 months post use of the previously reported evercross balloon and 5 months post use of another powercross balloon, occlusion of the left sfa occurred.The patient was treated by pta balloon catheters.It is reported that the event is resolved.Patient has a history of diabetes, below the knee vascular disease of the left limb and previous peripheral revascularization of the left popliteal.
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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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Manufacturer Narrative
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(b)(4) assessment at the time of the original index procedure was ischemic rest pain.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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