|
Event identified from lee, s.J.Et al (2013).Coil embolization using the self-expandable closed-cell stent for intracranial saccular aneurysm: a single-center experience of 289 consecutive aneurysm, clinical radiology , 68 (2013) 256-263.No lot number was reported therefore no device history record review could be performed.Thromboembolic events, extravasation/bleeding from the aneurysm wall, cerebral infarctions and in-stent stenosis are known potential adverse events associated with the use of the enterprise vrd device and are listed in the ifu as such.Stent malposition and migration are known potential product malfunctions associated with the use of the enterprise vrd device and the ifu gives cautions regarding both of these events.There were no reported catalogue or lot numbers and the complaint devices remain implanted thus neither the dhr nor fal could be performed for these devices.However, all products undergo a 100% inspection for quality prior to being released for distribution.All of the studied patients were started and maintained on dual anti-platelet medication regimens with varying degrees of patient compliance.There were multiple locations, sizes and conformation of the aneurysms involved in the 3 year study of stent assisted coil embolization.Review of the available information suggests that patient, procedural, aneurysm characteristic, handling of the device and medication factors may have all contributed to the varied reported events.Note: the article was reviewed in august 2012 however the dates of the individual events are unknown.Event date is captured as (b)(6), 2012.This report is related to mfr report # 1058196-2015-00195, 1058196-2015-00196, 1058196-2015-00197, 1058196-2015-00198, 1058196-2015-00200.
|
|
As reported via a literature article (lee, s.J.Et al (2013).Coil embolization using the self-expandable closed-cell stent for intracranial saccular aneurysm: a single-center experience of 289 consecutive aneurysm, clinical radiology , 68 (2013) 256-263) in 289 aneurysms treated with enterprise stent (lot/catalog unknown) assisted coil embolization, there were 24 thromboembolic events, 1 transient cranial nerve palsy by mass effect, 2 procedural aneurysmal leaks, 5 early delayed infarctions, 11 delayed infarctions, 14 in-stent stenoses, 2 stent malpositions, and 5 stent migrations.The article assessed the clinical and morphological outcomes of 261 consecutive patients with a total of 289 aneurysms that were treated with a stent-protected coiling technique using the enterprise stent from june 2008 to august 2011.Thromboembolic complications occurred in 19 patients (24 aneurysms).Asymptomatic thromboembolism occurred in 15 patients, symptomatic thromboembolic infarction in four.Six of the thromboembolic events occurred in patients who had ruptured aneurysms, causing permanent sequelae in one patient.The author noted that the thromboembolic events in ruptured aneurysms might be due to limitations of the anti-platelet preparation and anti-coagulant use.In the remaining 18 un-ruptured aneurysms, additional anti-platelet agent was added to maintenance therapy after which repeat ischemia did not develop, except in one case with poor compliance.Patients with un-ruptured aneurysms were give loading doses of clopidogrel and aspirin pre-procedure and a bolus of 3000 iu of heparin with intermittent boluses of 1000 iu heparin per hour.Upon completion of the procedure, tirofiban or heparin was maintained for up to 12 hours in cases involving procedural thromboembolism.Dual antiplatelet medication was also recommended to be maintained for at least 1 month after the procedure, and a single agent was to be maintained for a least a year.In patients with ruptured aneurysm, systemic heparinization was initiated after adequate protection of the aneurysm.After the procedure, a loading does of clopidogrel was administered, and single or dual agents were maintained for a least 1 year, depending on the presence of intracerebral hemorrhage, clopidogrel resistance, and side effects of medications.The article mentioned that there was procedural aneurysmal leakage in two patients, but also mentioned that one patient experienced procedural leakage, but fully recovered.Early delayed infarction occurred in five patients and the infarction territory was related to coil embolization.Among them, one patient suffered permanent sequelae.Late delayed infarction was observed in 11 patients.Three patients had poor compliance for anti-platelet maintenance, and five experienced delayed stroke after cessation of clopidogrel, while still maintaining another anti-platelet medication.Two patients who were poor responders to clopidogrel experienced infarction after the cessation of aspirin, while still maintaining clopidogrel.The other patient, who demonstrated clopidogrel resistance, suffered infarction during the maintenance of dual anti-platelet medication.After the patient changed to triple medication, additional infarctions did not occur.One of the delayed infarctions was associated with recanalization.Among patients who experienced delayed infarction, five suffered permanent sequelae.Follow-up conventional angiography performed more than 1 month after coil embolization revealed in-stent stenosis in 14 aneurysms, including mild stenosis in 10 aneurysms and moderate stenosis in four.No patients suffered neurological symptoms due to in-stent stenosis except for one patient.In one patient , following treatment of a basilar tip aneurysm with coil embolization and enterprise stenting, subtotal occlusion was achieved.At 1 year follow-up, angiography showed significant in-stent stenosis and the aneurysm was recanalized.The patient underwent re-embolization with coils.Stent malposition occurred in two aneurysms (0.7%), and each of the cases showed that a branch originated from the parent artery with an acute angle.There were concerns that the stent might induce branch occlusion or narrowing due to stent kinking by the nature of the closed-cell stent.Therefore, the intended was to cover the neck of the aneurysm with the proximal portion of the stent.However, the stent was located distal to the aneurysm neck due to vessel tortuosity.There was no report of injury with regard to the issue.Stent migration was observed in five patients, including distal migration in four, and proximal migration in one.Four of the migrations occurred during the procedure.In two cases, the migrated stents were located disproportionally between the parent artery and the branch artery and migrated distally; however, the migration was insignificant, and the stent covered the aneurysm.In another two cases, the stents were located only in a branch artery, in which the proximal portion of the stent covered the neck of the aneurysm.In one of these cases, the stent pusher was not retrieved due to vessel tortuosity after proper deployment.During the struggle to retrieve the stent pusher, the stent migrated distally and the proximal portion flared into the aneurysm.The other migration occurred in a case of stent malposition, in which the stent was positioned only in angulated branch artery.There was no report of injury related to stent migration.
|
