(b)(4).Pma/510(k) #p100022/s001.This investigation captures the restenosis of ziv6-35-125-6.0-120-ptx ptx stent of lot c778568 placed in left sfa of a female patient (b)(6) 2012).Ref also: 3001845648-2017-00500 and 3001845648-2017-00501.The ziv6-35-125-6.0-120-ptx stent of lot number c778568 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It was stated by the originator in the complaint file that there are no images available for review and no further information will be available.The patient had the following pre-existing conditions: coronary artery disease, carotid artery disease, hypertension, diabetes, hypercholesterolemia and renal disease.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.It may be noted that surface of the zilver ptx stent is coated with the drug (paclitaxel) to help prevent subsequent restenosis of the artery.It can be therefore stated that it is very unlikely that the reported restenosis could have occurred due to zilver ptx malfunction; however as no imaging was available at the time of investigation, a definitive root cause of this event cannot be determined at this time.In addition worsened claudication was also observed on the patient.It can be noted that this symptom indicates progression of peripheral artery disease and can also be associated with the restenosis process.It may be noted that as per the packaging insert, restenosis of the stented artery is a known potential adverse event associated with the placement of this device.In addition to this, worsened claudication is also a potential adverse event as per the packaging insert.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has occurred previously with the lot number c778568.However based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c778568.Pta was conducted against the stenosis on the same day and the patient's condition was recovered.Complaints of this nature will continue to be monitored for any potential emerging trends.
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Fda mdr report required based on the surgical intervention (pta) carried out due to the occurrence of restenosis after zilver ptx implantation.On (b)(6) 2012 three ptx stents below were placed in left sfa of a female patient.Ziv6-35-125-6.0-120-ptx, lot#c778568; ziv6-35-125-6.0-120-ptx, lot#c777373; ziv6-35-125-6.0-60-ptx, lot#c778439.On (b)(6) 2017 restenosis in the stented lesion was confirmed (pr202837, 202838, 202839).Worsened intermittent claudication was observed on the patient.Pta was conducted against the stenosis on the same day and the patient's condition was recovered.
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