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Pma/510(k) # p050017/s002 and s003.(b)(4).(b)(6).Importer site establishment registration number: (b)(4).Problem statement: as reported to customer relations, "stent delivery system was delivered with difficultly across bifurcation and to left sfa (superficial femoral artery) occlusion.During delivery of zilver ptx stent the delivery wheel stopped moving and eventually snapped.Md (physician) had break apart handle of delivery systems to manually complete the stent placement.Procedure finished without further issues.Another stent from another manufacturer was placed through the zilver ptx to complete study." device evaluation: the zisv6-35-125-6-120-ptx device of lot number c1448768 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The investigation will be updated once the device has been returned and evaluated.From customer, it is known that the complaint device was advanced over a glide wire wireguide, of unknown diameter.The device was flushed prior to use.The stent was fully deployed by opening the device handle.The patient anatomy was both tortuous and calcified.Pre-dilation was conducted prior to stent deployment.It is known that the patient was tasc ii (transatlantic society's consensus) classification c and d, and had previously implanted stent in both iliac arteries.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Possible causes for this occurrence could include the tortuous or calcified anatomy, the difficult anatomy could have created resistance during deployment.The resistance could have caused or contributed to the thumbwheel mechanism malfunctioning, and the inability to deploy the stent.However, as the device has not yet been returned and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use.Document review: prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.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 not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with this lot number.It may be noted that the failure mode of "deployment difficult" has been provisionally assigned.The final failure mode will be confirmed following device return and evaluation.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk will be assessed for this complaint when the device is evaluated, and once completed the investigation will be updated with the risk details.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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Pma/510(k) # p050017/s002 and s003.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Problem statement.As reported to customer relations, "stent delivery system was delivered with difficultly across bifurcation and to left sfa (superficial femoral artery) occlusion.During delivery of zilver ptx stent the delivery wheel stopped moving and eventually snapped.Md (physician) had break apart handle of delivery systems to manually complete the stent placement.Procedure finished without further issues.Another stent from another manufacturer was placed through the zilver ptx to complete study." device evaluation.The zisv6-35-125-6-120-ptx device involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.From customer, it is known that the complaint device was flushed prior to use.The stent was fully deployed by opening the device handle.The patient anatomy was both tortuous and calcified.Pre-dilation was conducted prior to stent deployment.It is known that the patient was tasc ii (transatlantic society's consensus) classification c and d, and had previously implanted stent in both iliac arteries.The device related to this occurrence underwent a laboratory evaluation on the 12th april 2018.On evaluation of the returned device, it was noted that the device was returned with the handle disassembled.Several components were not returned with the device, including the pulley, pawl, stent retraction sheath (srs), stability sheath (ss), strain relief, the proximal inner and the overmould.There was evidence that the retraction wire had separated from the stent retraction sheath.The customer provided additional information.The device was advanced over a 0.035¿ diameter wire guide.The missing components were not kept by the customer.A 6fr ansel sheath was used.The aortic bifurcation was steep and previously stented.The customer confirmed that another stent was placed to cover the lesion and the complaint device stent.There was only one zilver ptx stent involved in this complaint, and was the complaint device.Images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Is the complaint confirmed? no.The complaint is not confirmed as imaging of the zisv6-35-125-6-120-ptx was not provided.Observation of device effects, relative to the patient's anatomy: because the provided images' relationship to the procedure cannot be verified, the only definite conclusion that can be made is that a very steep aortic bifurcation was further accentuated by pre-existing kissing iliac artery wallstents.Observation of device effects, relative to the disease state: none.Observation of significant findings relative to the use of the device: none.Observation of additional device findings relative to the clinical perspective: none.Findings: 1.A single, limited quality, subtracted angiographic image from a pelvic angiograms provided along with the complaint report.Imaging of the zisv6-35-125-6-120-ptx was not provided.2.The complaint report states that the target lesion was the left superficial femoral artery (sfa) rather than the right, as depicted on the provided image.Since the bone is completely subtracted on the image, sidedness cannot be determined.There are three possible explanations.First, the complaint report should have stated that the right sfa was the target lesion.Second, the image was flipped right to left.Third, the image was performed during a different intervention and was provided only to illustrate the anatomic difficulty.3.This third explanation was most likely for two additional reasons.First, a wire, that's tip was in the right external iliac artery (eia) and had been introduced from a left up and over approach, appeared more robust than the reported glide wire.Second, the tip of a braided left common femoral artery (cfa) sheath that had been advanced to the proximal left eia appeared larger than a 6f sheath used for zisv6-35-125-6-120-ptx implantation.4.Kissing wallstents extend from the distal aorta into the proximal eias.5.The guide wire transgressed the interstices of both stents.Impression: 1.The complaint is not confirmed as imaging of the zisv6-35-125-6-120-ptx was not provided.2.Because the provided images' relationship to the procedure cannot be verified, the only definite conclusion that can be made is that a very steep aortic bifurcation was further accentuated by pre-existing kissing iliac artery wallstents.3.Because the zisv6-35-125-6-120-ptx support sheath or an introducer sheath would have been in contact with the wallstents, whether on top of or through their interstices, the wallstents could have only impeded the retraction sheath by exacerbating the steepness of the bifurcation and not by friction from their wires.4.Because the stent was successfully deployed by taking apart the handle, the retraction ribbon could not have separated from the retraction sheath.Complaint is confirmed as the failure was verified in the laboratory.There was evidence that the retraction wire had separated from the stent retraction sheath.It may be noted that while the image review suggested that the retraction wire could not have separated from the stent retraction sheath, the laboratory evaluation found physical evidence of the separation.Possible causes for this occurrence could include the tortuous or calcified anatomy.From the image review, it was suggested that the aortic bifurcation was steep, and from customer testimony it is known that the patient anatomy was calcified and tortuous.The difficult anatomy could have created resistance during deployment.The resistance could have caused or contributed to the retraction wire separating from the stent retraction sheath.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use.A capa (pr216126) has been initiated to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.Document review prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.A review of the relevant manufacturing record revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with this lot number.Summary complaint is confirmed as the failure was verified in the laboratory.There was evidence that the retraction wire had separated from the stent retraction sheath.The risk was determined to be low (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The complaint stent was covered with another stent.Complaints of this nature will continue to be monitored for potential emerging trends.
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