MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZISV6-35-80-6.0-120-PTX

Device Problem Break (1069)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # = p100022/s014.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Report is being submitted under serious injury as the stent fractured (precedence), re-stenosis occurred and needed to be replaced.Physician informed rep that they had issues with zisv6**ptx the stent showed a fractured structure and needed to be replaced.This occurred after 1.5 years after implantation.No lot or specific size was confirmed rep will provide copies of pictures taken for evaluation the patient came back with new discomfort in the leg.When dr.(b)(6) did the angiogram, he saw 2 stents fractures, which, in his eyes, led to a restenosis of the vessel.He did a instent-stenting with another z-ptx.

Manufacturer Narrative

Pma/510(k) # = p100022/s014.(b)(4).Exemption number: e2016031.(b)(4).Device evaluation: the zisv6-35-80-6.0-120-ptx device of lot number c1269116 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony it is known that the device was placed in the superficial femoral artery (sfa) by contralateral approach.The customer confirmed the patient¿s anatomy was calcified at the time of the initial intervention.Pre-dilation was performed prior to stent placement.The device was flushed per the instructions for use (ifu).Post-dilation was performed after stent placement.Details of the wire guide and access sheath used are unknown.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? yes.A type iv fracture and a less severe, type ill or less fracture, is confirmed.The stent may not be a zilver ptx stent.This is based particularly on the rounder than usual end markers but also on a shorter than expected length of individual stent rows.Observation of device effects, relative to the patient's anatomy: none focused angulations of the severely calcified and elongated artery would have placed severe repetitive stress on the artery with knee flexion.Since the stent was fully expanded, repetitive, focused bending rather than insufficient radial force likely caused the fractures.Observation of significant findings relative to the use of the device: none.Observation of additional device findings relative to the clinical perspective: neointimal hyperplasia would have been exacerbated by the fractures and is consistent with the reported occlusion.Other (as requested in complaint review intake form): none.Findings: 1.Two x-ray images of a right distal sfa (superficial femoral artery) into popliteal artery stent are provided along with the complaint report.2.The stent cannot be confirmed as a zilver stent because the proximal markers appear rounder than expected and the length of individual stent rows slightly shorter.3.Because the distal most centimetre of the stent was not included on the images, stent length cannot be confirmed.4.The artery was severely calcified and elongated.Rather than becoming gradually tortuous, the elongated artery was abruptly angled in three locations.This was secondary to densely calcified plaque that was up to 6mm thick through long segments.Overall artery diameter including the plaque varied between 11 and 16mm.This converted the artery from a flexible muscular tube to a series of rigid pipes articulating at points where the calcification had fractured.5.Fractures were located at the points of angulation.A type iv fracture involved the proximal half of the stent.This portion of the stent extended across the adductor canal segment of the sfa, the segment of the sfa subjected to the greatest stress and the typical location of the most severe disease.6.Consistent with a type iv fracture, a central free fragment was mal-aligned relative to the lumen.The mal-alignment was the result of acute artery angulation.The mal-alignment created stenosis and would have exacerbated neointimal hyperplasia.Impression: 1.A type iv fracture and a less severe, type iii or less fracture, is confirmed.The stent may not be a zilver ptx stent.This is based particularly on the rounder than usual end markers but also on a shorter than expected length of individual stent rows.2.Focused angulations of the severely calcified and elongated artery would have placed severe repetitive stress on the artery with knee flexion.Since the stent was fully expanded, repetitive, focused bending rather than insufficient force likely caused the fractures.3.Neointimal hyperplasia would have been exacerbated by the fractures and is consistent with the reported occlusion.The complaint is confirmed as a type iv fracture and a less severe, type iii or less fracture, is confirmed in the image review.As stated in the image review ¿since the stent was fully expanded, repetitive, focused bending rather than insufficient force likely caused the fractures.¿ the stent fracture also caused the reported occlusion.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 (ifu0117-2).It can be noted that ¿stent structure fracture¿ and ¿restenosis of the stented artery¿ are listed as possible adverse effects in the ifu.It should be noted that the restenosis in this case was due to the stent fracture.Upon review of the imaging review report for this complaint, it seems that the stent in question may not have been a zilver ptx stent.A request was made to determine whether or not the correct images were forwarded to cirl and to determine if a zilver ptx thumbwheel device had been used during the procedure.The sales rep informed cirl that the images were most likely correct however, this cannot be proven.Given that the stent was implanted over 1.5 years ago and the sales rep did not attend the case, it would be difficult to verify the accuracy of the complaint information.If additional information regarding the device used or the images forwarded for review becomes available the investigation will be updated.Document review: a review of incoming qc records did not reveal any issues which could have contributed to this complaint issue 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 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 lot number c1269116.Summary: the complaint is confirmed as a type iv fracture and a less severe, type iii or less fracture, is confirmed in the image review.The risk was determined to be risk category iii/low.According to the initial reporter, the patient reported discomfort in the leg and re-intervention due to stent fracture was required.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Report is being submitted under serious injury as the stent fractured (precedence), re-stenosis occurred and needed to be replaced.Physician informed rep that they had issues with zisv6**ptx the stent showed a fractured structure and needed to be replaced.This occurred after 1.5 years after implantation.No lot or specific size was confirmed rep will provide copies of pictures taken for evaluation.The patient came back with new discomfort in the leg.When dr.(b)(6) did the angiogram, he saw 2 stents fractures, which, in his eyes, led to a restenosis of the vessel.He did a instent-stenting with another z-ptx."as per complaint form" (b)(6) 2017: first intervention (pta (percutaneous transluminal angioplasty), sfa (superficial femoral artery)-stenting with zilver ptx).(b)(6) 2018: the patient came back with new discomfort in the leg.When dr.(b)(6) did the angiogram, he saw 2 stents fractures, which, in his eyes, led to a restenosis of the vessel.He criticizes the radial force of the zptx.Fractures should not occur after 1 1/2 years.He did an instent-stenting with another zptx.The additional cost of reintervention does not seem to be reimbursed by the insurance.Since dr.(b)(6) thinks that the zilver ptx may no longer be used, he is encouraged in his opinion by this result.".

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7788537
• MDR Text Key: 117278662
• Report Number: 3001845648-2018-00373
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002353111
• UDI-Public: (01)10827002353111(17)170821(10)C1269116
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2017
• Device Catalogue Number: ZISV6-35-80-6.0-120-PTX
• Device Lot Number: C1269116
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention