|
Device Problems
Fracture (1260); Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/24/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Journal article: comparison of drug eluting versus bare metal stents for pulmonary vein stenosis in childhood journal: catheterization and cardiovascular interventions year: 2019 ref: doi: 10.1002/ccd.28328.Average age.Majority gender.Date of publication.Death was reported as a clinical outcome of this study, however there is no information to suggest the device has caused or contributed to a death.Medication: antiplatelet therapy, aspirin.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
A retrospective review of all stent implants for pulmonary vein stenosis (pvs) between august 1993 and november 2017 was conducted in this study.Resolute integrity rx coronary des was among the 111 drug eluting stents implanted in 41 patients to treat 105 lesions.Prior to implantation of stents, resistant lesions were prepared to abolish any residual waist.All patients were started on antiplatelet therapy within 24 hr of stent implant unless a contraindication existed.Post implantation three major complications were reported; bleeding in the endotracheal tube related to mechanical trauma during transfer, thrombus in the distal vein post stent implantation treated with aspiration thrombectomy and pulmonary haemorrhage noted a few days after catheterization.Initial and long term follow-up catheterizations included stent re-dilations, distal lesions treated with angioplasty and placement of new stents, lesions with repeat stenting with des for restenosis and complete occlusion.Multiple stents were intentionally fractured on follow-up catheterization to achieve diameter >6 mm.10 patient deaths were reported.Medtronic judkins right guide catheters were used during the procedures.No alleged product issue or adverse events reported for these devices.
|
|
Search Alerts/Recalls
|
|
|