(b)(4).Information pertaining to contact office as follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) #p100022/s001.This investigation captures the restenosis of ziv6-35-125-7.0-60-ptxstent of lot number c774345 on the (b)(6) 2017.Ref also: 3001845648-2017-00502.The device 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 that there are no images available for review.It is known the patient had the following pre-existing conditions:coronary 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 for review, a definitive root cause of this event cannot be determined.It may be noted that the packaging insert lists restenosis of the stented artery as a known potential adverse event associated with placement of this device.In addition worsened claudication is also listed as a potential adverse event associated with the placement in this device as per the packaging insert.A query is currently pending with the rep on where exactly the restenosis occurred (which stent? proximal or distal stent?) and if these two stents overlapped.The investigation will be updated on receipt of this information.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 c774345.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 c774345.Therefore no action required.The patient was treated with a cutting balloon and the patient recovered.No other adverse events were reported as a result of this occurrence.Complaints of this nature will continue to be monitored for any potential emerging trends.
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