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COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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| Catalog Number ZIV6-35-125-7-100-PTX |
| Device Problems
Difficult or Delayed Positioning (1157); Fracture (1260); Activation, Positioning or Separation Problem (2906)
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| Patient Problems
Thrombus (2101); Blockage (2332); Surgical procedure, delayed (2565)
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| Event Date 07/03/2015 |
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Event Type
Injury
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Event Description
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On (b)(6) 2015 the physician had difficulty deploying a ptx device.At the iliac, the tip of the stent broke off inside of the patient.The physician then placed an atrium stent.Angiography confirmed thrombosis.The physician put down an infusion catheter and dripped liddic overnight.On (b)(6) 2015 and (b)(6) 2015 it was noted that the vessels had still not opened.There has been no blood flow.The patient is being monitored.Vascular surgery was consulted for a possible below the knee amputation.No further updates or adverse effects to the patient have been reported.
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Manufacturer Narrative
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(b)(4).Description of event: 'on (b)(6) 2015 the reported ptx device was placed over a bulkin 6fr sheath wire and advanced on to the desired location.The physician began to deploy and the stent flowered so they stopped deploying, then attempted to deploy the stent again.The stent would not deploy.The physician attempted to pull back on delivery without damaging the vessel but the stent would not move.The physician gently tried to re-sheath the stent, just enough to get away from vessel wall.They physician was able to get it away from the wall and to the tip of balkin sheath.Now in the iliac, the top of the stent would not go into the sheath.At this point the tip of the stent broke off inside the patient.They physician took a balloon and attempted to plasty the stent to the iliac wall unsuccessfully.The physician then placed an atrium stent.Angiography confirmed thrombosis.An infusion catheter was placed and liddic dripped overnight.On (b)(6) 2015 and (b)(6) 2015 it was noted that the vessels had still not opened.There was no blood flow.Vascular surgery was consulted for a possible below the knee amputation.The patient is being monitored.No further updates or adverse effects to the patient have been reported.The information received relating to this event is currently being investigated.A follow up mdr will be submitted with the investigation conclusions.
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Manufacturer Narrative
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This complaint is reportable to the fda on the basis of the reporting precedence established for this product family for stent fracture, regardless of the patient outcome.In this incident intervention was also performed (attempt to plasty the stent to the iliac wall, placement of a balloon expandable 8mmx 56mm atrium covered stent, vascular surgery was consulted for below the knee amputation).
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Event Description
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This follow up report is being submitted to include the investigation conclusions.On (b)(6) 2015 the physician wanted to stent the fsa due to the dissection.The physician had a.035 glidewire in place.The ptx was flushed properly and the physician put it over the wire to location desired.The distal markers were lined up.Physician told the district manager he felt more resistance than with the 6 diameter device used previously.The physician began to deploy and the stent flowered.Physician stopped then attempted to deploy again and the stent would not deploy.The district manager stopped the physician and evaluated what to do next.The physician attempted to pull back on delivery without damaging the vessel and it would not move.The physician gently tried to re-sheath the stent, not completely just enough to get away from vessel wall.The physician was able to get it away from the wall and to the tip of balkin sheath.Now in the iliac, the top of the stent would not go in to the sheath.At this point the tip of the stent broke off inside of the patient.The physician, took an 8x4 balloon and attempted to plasty the stent to the iliac wall unsuccessfully.The physician then placed a balloon expandable 8mmx 56mm atrium covered stent.Another angiogram was done from common femoral and all the way down was thrombosed.The physician put down an infusion catheter and dripped liddic overnight.On (b)(6) 2015, the physician re-evaluated and noted the vessels still had not opened.On (b)(6) 2015 the patient was brought back and the vessels were still not opened.Vascular surgery was consulted for below the knee amputation.
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Manufacturer Narrative
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This complaint is reportable to the fda on the basis of the reporting precedence established for this product family for stent fracture, regardless of the patient outcome.In this incident intervention was also performed (attempt to plasty the stent to the iliac wall, placement of a balloon expandable 8mmx 56mm atrium covered stent, vascular surgery was consulted for below the knee amputation) the 1 x ziv6-35-125-7-100-ptx device of lot number c1080362 was returned to for evaluation.Device was returned in the original packaging and was open on receipt.Access sheath used during the procedure has been also provided for evaluation.On evaluation of the returned device it was evident that the stent was returned separately and that distal part of the stent was damaged.Further visual examination of the returned stent revealed missing gold rivets, confirming stent fracture.Using calibrated ruler, the returned stent measured approx.9.5cm, demonstrating that approx.0.5cm was missing.This is consistent with the complaint information provided, which indicated that fractured portion of the stent was left in the patient and was stented over with another manufacturer¿s stent.Access sheath was visually examined and no issues were noticed.Using calibrated ruler, the outer sheath measured 127.5 cm and was noted to be elongated (specification 125.0cm + 1.0cm/ - 2.0cm).The entire device has been examined for damage and tactile damage was detected.Flexor coils could be felt along the flexor length which would explain delivery system elongation.Using 1ml syringe with water, device was flushed through the flushing ports and no issues were noted.Delivery system was advanced over the non hydrophilic 0.035¿¿ wire guide and resistance was encountered when passing the wire guide through the connector cap.Outer sheath was disassembled and examined.Slight kink on the inner catheter was observed in the region of connector cap.This kink contributed to resistance when advancing the device over the wire guide.This kink most likely occurred after the procedure as it has been confirmed that there was no advancement difficulty during the procedure.Distal end of the inner catheter was visually examined.No excess glue and no damage or indentation was evident on the edge of the pusher ring.From the examination of the returned device there is no evidence to suggest that the device was manufactured incorrectly.Upon evaluation of the returned device, the customer complaint can be confirmed as stent fracture was evident.Complaint information indicates that resistance during deployment was encountered.Outer sheath elongation evident during laboratory evaluation confirms that the user did experience difficulty during deployment.Outer sheath elongation can be attributed to high deployment forces that occurred during the procedure.The following factors may have contributed to the deployment difficulty: a design issue related to stent deployment.Deficiency of the outer sheath (project has been completed to improve the performance of the sheath and overall deployment of the device).User technique - it was noted that the user stopped stent deployment after the stent ¿flowered¿.As per the information included in the ifu, once deployment has been started it should be continued until the stent is deployed.Patient anatomy (difficult anatomy configuration, severe calcification, etc.Could have caused additional friction during stent deployment.It can be noted however that the first stent was deployed without difficulty).Due to experienced deployment difficulty, the user decided to pull back the whole delivery system and also attempted to re-sheath the stent.It can be noted that ifu states that repositioning of the device after deployment is not possible since the introducer catheter cannot be re-advanced over the stent.Pulling delivery system with partially deployed stent resulted in stent fracture because the expanded stent could not be inserted into the access sheath.However, as no imaging was provided to support the complaint investigation and as the conditions of use cannot be replicated in the laboratory settings, it was not possible to conclusively determine the root cause of the reported event.It was noted that following placement of balloon expandable 8mmx56mm atrium covered stent, angiography showed that patient¿s artery was thrombosed.Prolonged procedure most likely contributed to this event, however as no imaging was provided; no other comments can be made.Anti thrombolytic agents were given for 4-6hrs however the vessels were still not opened so below the knee amputation has been conducted.According to instruction for use stent strut fracture is a known potential adverse event associated with the placement of this device.In addition, the following information is provided: ¿the majority of stent fractures in clinical studies were associated with stent elongation = 10% at deployment.Therefore, care should be taken to hold the hub stationary and to remove any slack in the introducer catheter to ensure the stent is not stretched or compressed lengthwise during deployment.¿ ¿do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device¿.¿once stent deployment has begun, the stent must be fully deployed.Repositioning of the zilver ptx drug-eluting peripheral stent is not possible since the delivery system¿s outer sheath cannot be re-advanced over the stent once deployment begins¿.¿as deployment occurs, continue sliding the handle toward the hub in a slow, smooth and consistent fashion¿.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.According to the initial reporter, fractured portion of the stent was stented over with another manufacturer¿s stent.Anti thrombolytic agents were given for 4-6hrs however the vessels were still not opened so below the knee amputation has been conducted.It can be noted that the patient was already a candidate for below the ankle amputation.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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Event Description
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(b)(4).On (b)(6) 2015 the physician wanted to stent the fsa due to the dissection.The physician had a.035 glidewire in place.The ptx was flushed properly and the physician put it over the wire to location desired.The distal markers were lined up.Physician told the district manager he felt more resistance than with the 6 diameter device used previously.The physician began to deploy and the stent flowered.Physician stopped then attempted to deploy again and the stent would not deploy.The district manager stopped the physician and evaluated what to do next.The physician attempted to pull back on delivery without damaging the vessel and it would not move.The physician gently tried to re-sheath the stent, not completely just enough to get away from vessel wall.The physician was able to get it away from the wall and to the tip of balkin sheath.Now in the iliac, the top of the stent would not go in to the sheath.At this point the tip of the stent broke off inside of the patient.The physician, took an 8x4 balloon and attempted to plasty the stent to the iliac wall unsuccessfully.The physician then placed a balloon expandable 8mmx 56mm atrium covered stent.Another angiogram was done from common femoral and all the way down was thrombosed.The physician put down an infusion catheter and dripped liddic overnight.On (b)(6) 2015, the physician re-evaluated and noted the vessels still had not opened.On (b)(6) 2015 the patient was brought back and the vessels were still not opened.Vascular surgery was consulted for below the knee amputation.
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