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

Catalog Number ZIV6-35-125-6.0 80-PTX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

As part of an image review conducted in relation to mdr report ref # 3001845648-2014-00320 a second zilver ptx stent was identified as having mild compression.Complaint details received in relation to mdr report ref #3001845648-2014-00320 did not indicate any issue with a second zilver ptx stent.Upon follow up with the user facility relating to this new information re a second stent, the user facility indicated no issue with deployment occurred with this stent and that this was the first stent deployed during the procedure.No adverse effects to the patient have been reported as occurring as a result of this special event.The procedure was successfully finished with another device.

Manufacturer Narrative

The pma/510(k)#: p100022 and s001.(b)(4).Incident meets fda mdr reporting requirements based on the reporting precedence established for this product family for 'stent shortening'; regardless of patient outcome.The zilver ptx device involved in this complaint was implanted in the patient therefore is not available for evaluation.With the information provided, a document based investigation was carried out.During the image review for mdr report ref# 3001845648-2014-00320, it was noted that the first zilver ptx stent was deployed with some mild compression.The findings from this image review were as follows: findings: angiography from stent deployment is provided.Actual stent deployment imaging is not provided and likely was not recorded.This is customary.The approach was antegrade at a very acute angle, approaching 90 degrees.The access sheath kinked and twisted on entering the common femoral artery.The lesion was a distal sfa into popliteal artery occlusion extending to the knee joint with an overall lesion length of 135mm.The occlusion was recanalized and appropriately pre-angioplastied.It was severely irregular as should be expected after angioplasty.The mid stent did deploy in a concertinaed fashion as described in the complaint report.The other two stents deployed normally but the distal stent was slightly compressed.The calibration tape on the table does not correlate with the measured lengths provided on the imaging.The measured lengths must have been performed through automatic calibration software of the siemens axiom artis used to perform this exam.Repeat measuring of the tape based on the automatic calibration software supports that the patient was near isocenter and the calibration software appropriately adjusted to image a leg vessel rather than an abdominal vessel.The distal stent length is 76mm and the proximal stent length is 60mm.The concertinaed stent length is 65mm.The proximal stent was placed inside the concertinaed segment and could not completely expand.Although the stenosis was created by the concertinaed stent on post deployment angiography, this is because contrast flowed through the disordered stent interstices.Once intimal incorporation of the stent occurs, a stenosis should be anticipated.Impression: the mid stent did deploy in a concertinaed fashion with 35mm of shortening.The reason is multifactorial.First, the stent was likely deployed with some forward pressure.The operator deployed the first stent successfully with some mild compression.The same forward pressure likely was exerted during the second stent deployment.The third stent was deployed to its design length likely because the operator was now keenly aware to avoid forward pressure.Second, the steepness of the ipsilateral approach reduces operator tactile feedback causing as much or more friction than a very steep aortic bifurcation.Consequently forces are increased and motion translated through the delivery system is often abrupt rather than smooth.Third, because the ipsilateral antegrade approach requires the operator to suspended 135cm delivery system in mid-air, keeping the cannula motionless is significantly more difficult particularly when such an acute access angle is present.Last, all self-expanding stents with a partially closed cell design such as the zilver ptx can seem to self-deploy if the stent apices become entrapped at angles in the vessel wall or in adjacent stent as they are revealed.The effect is to shorten the stent.Although this cannot account for this amount of concertinaed stent, it can significantly aggravate shortening conjunction with unintended delivery cannula advancement.The segment will likely become flow limiting with intimal covering.This could be addressed with short-term angiographic surveillance and angioplasty if necessary.Additional information confirmed that the patient suffered peripheral vascular disease.A possible cause of this event may be due to the patients tortuous anatomy, however, as the device is not available for evaluation a definite root cause cannot be conclusively determined.Based on the image review and additional information received, the complaint was confirmed.A review of the manufacturing records revealed no discrepancies related to this complaint issue.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.The instructions for use contain specific instructions for stent deployment.The doctor reported no problems with this first stent.No adverse effects to the patient were reported.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr. specialist ; 61334440
• MDR Report Key: 4376727
• MDR Text Key: 5119068
• Report Number: 3001845648-2014-00344
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: NZ
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2015
• Device Catalogue Number: ZIV6-35-125-6.0 80-PTX
• Device Lot Number: C966550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR