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Model Number 20201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Restenosis (4576)
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Event Date 03/28/2024 |
Event Type
Injury
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Manufacturer Narrative
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Implant date: the implant date is unknown and was estimated to the first day of (b)(6) 2023.
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Event Description
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It was reported that restenosis occurred.On (b)(6), a 7.0mmx19mmx150cm express vascular sd stent-balloon expandable was implanted for treatment.On april 2, 2024, the patient was diagnosed with fibro mediastinitis and pulmonary vein stenosis in the previously implanted express sd stent.The 80% stenosed target lesion was located in the severely tortuous pulmonary vein artery.An interventional therapy of intrastent restenosis drug-balloon dilation was performed.During the procedure, a 0.18 guidewire was used to cross the lesion with an 8f non-boston scientific guide catheter.A 7.0 mm x 30 mm, 135 cm ranger drug-coated balloon (dcb) was advanced, but the lesion site was relatively serious, it could not cross the lesion even after repeated attempts.The physician then removed the device and treat the lesion with another drug-coated balloon.No complications were reported, and the patient status was stable.It was unknown if the device will be return for analysis.
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Manufacturer Narrative
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D6a implant date: the implant date is unknown and was estimated to (b)(6) 2023.Correction of b3 date of event from 04/02/2024 to 03/28/2024.
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Event Description
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It was reported that restenosis occurred.On (b)(6) 2023, a 7.0mmx19mmx150cm express vascular sd stent-balloon expandable was implanted for treatment.On (b)(6) 2024, the patient was diagnosed with fibro mediastinitis and pulmonary vein stenosis in the previously implanted express sd stent.The 80% stenosed target lesion was located in the severely tortuous pulmonary vein artery.An interventional therapy of intrastent restenosis drug-balloon dilation was performed.During the procedure, a 0.18 guidewire was used to cross the lesion with an 8f non-boston scientific guide catheter.A 7.0 mm x 30 mm, 135 cm ranger drug-coated balloon (dcb) was advanced, but the lesion site was relatively serious, it could not cross the lesion even after repeated attempts.The physician then removed the device and treat the lesion with another drug-coated balloon.No complications were reported, and the patient status was stable.It was further reported that the restenosis was found during re-examination on (b)(6) 2024.
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Search Alerts/Recalls
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