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

Catalog Number ZIV6-35-125-7.0-120-PTX

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Pseudoaneurysm (2605); No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2013

Event Type  Injury  

Event Description

On (b)(6) 2012, three ptx stents (1x ziv6-35-125-7.0-120-ptx and 2x ziv6-35-125-6.0-120-ptx) were implanted in the left sfa of a patient.The blood flow of the lesion after the procedure was good.Follow up angiography was conducted one year after initial procedure.A clinical review of images provided in relation to this event revealed multiple stent fractures on the proximal and most distal zilver stents.The distal stent was transected and the distal segment displaced inferiorly.The proximal stent had two sites of fracture and had also migrated superiorly.Striking aneurysmal spaces were also noted to have developed in the sfa wall and the stents.The spaces are larger proximally and lessen distally once the mid sfa is reached.As the blood flow was good, no intervention has been performed to date.The physician plans to perform a follow up action.As per the complaint description received, three devices are involved in this incident.Additional separate reports will be submitted in relation to the other device reported - report reference numbers: 3001845648-2014-00155 and 3001845648-2014-00156.

Manufacturer Narrative

Additional pma/510(k) number: s001.This report is being submitted for the proximal zilver ptx device reported for stent fracture, stent migration and striking aneurysmal spaces/ pseudoaneurysm (ziv6-35-125-7.0-120-ptx, lot no: c781239).The zilver ptx device involved in this complaint is as follows; ziv6-35-125-7.0-120-ptx of lot number c781239.The device involved in this complaint was implanted in the patient and therefore not available to be returned for evaluation; with the information provided a document based investigation was carried out.A review of the relevant manufacturing records did not reveal any discrepancy which could have contributed to the complaint issue.Angiogram images were provided to support the complaint investigation and the following clinical image review was provided: "findings: the initial angiography demonstrates primary stenting of a long left superficial femoral artery (sfa) occlusion from femoral and popliteal access points.The entire sfa was occluded.Recanalization was performed from distal to proximal using sub-intimal technique however the wire was much farther outside the lumen than usual and at least in the adventitia if not extravascular.Revascularization was accomplished with three overlapping zilver ptx stents extending from the mid left common femoral artery (cfa) to the distal left sfa past the adductor canal.A left common femoral artery aneurysm was present and the patient was reported to have a aaa but no imaging of this was provided.Follow-up left leg angiography apparently performed coincidentally at the time of coronary angiography was performed 11 and 12 months post initial stenting.Angiography and stenting of the right coronary artery was performed on (b)(6) 2013.No follow up imaging of an uncoated coronary stent as suggested in the complaint report is provided.Multiple stent fractures are evident on each follow up angiograms involving the proximal and distal most zilver stents.Two sites of fracture involve the proximal stent.Each involves more than two struts but one is without deformation (type ii) and the other is likely transected (type iii).The stent has also migrated superiorly approximately 5mm and resulted in disconnection between it and the mid sfa stent.Striking aneurysmal spaces have developed in the sfa wall and the stents on angiography.The spaces are larger proximally and lessen distally once the mid sfa stent is reached.The space at the proximal disconnection is similar to the adjacent spaces and the artery is near normal at the mid and distal stent overlap point.The angiogram did not appreciably change during the month between follow-ups.The aneurysmal spaces are consistent with pseudoaneurysms.The pseudoaneurysms are largest around the middle and proximal stents.Post recanalization and angioplasty angiography demonstrated a dissected and occluded sfa matching the future pseudoaneurysm location.Additionally the severity of the pseudoaneurysm formation matches the degree to which the recanalization tract strayed from the vessel true lumen.Proximally where the true lumen was at least 4-5 mm outside the true lumen, the pseudoaneurysms were most severe.Distally where the channel was closer to true lumen, the pseudoaneurysms were less severe.Impression: striking spaces did develop between the stents and the sfa wall particularly in the proximal and mid left sfa.The most likely explanation is stent placement outside (in the adventitia) of the artery with the aneurysmal appearance representing pseudoaneurysm formation.Concluding that this was impossible given the normal immediate post stent appearance might be considered reasonable at face value; however, a case demonstrating a normal immediate post stent appearance with delayed pseudoaneurysm formation has been published (j vasc surg 2010; 52:216-8).Infection is possible but unlikely given the lack of clinical data supporting infection.Rarely unrecognized connective tissue disorder can result in aneurysm formation after characterization however these cases usually occur in young patients.Given drug coating must create dilated perivascular spaces at a cellular level, perivascular space size should not depend on the original vessel diameter.Although sizes of dilated perivascular spaces are not well described, the coronary literature provides a general range between 0.7 mm to 1.7 mm (circulation.2011;123:2382-2391) with larger spaces called aneurysms.The perivascular spaces in this case are much larger than would be anticipated from local drug effect and also should be called aneurysms.Additionally, these spaces are easily recognizable and if secondary to paclitaxel should have been evident not only in the clinical trial but in subsequent peer review literature.However aneurysms have yet to be reported in the sfa.The stent fractures are secondary to increased mobility of the stents inside the aneurysmal sfa.Sfa thrombosis secondary to stent fracture is possible." as the device was not available for evaluation and conditions of use cannot be replicated in the laboratory, it is not possible to conclusively determine the root cause for this complaint.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 for zilver ptx and zilver ptx drug eluting stent revealed no discrepancies that could have contributed to this complaint.As per the devices' instructions for use, stent strut fracture, stent migration, arterial aneurysm and pseudoaneurysm formation are noted as potential adverse events associated with the placement of these devices.The patient continues to be monitored and no further adverse effects have been reported.Complaints of this nature will continue to be monitored for potential merging 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: tracy o'sullivan ; EI ; 61334440
• MDR Report Key: 4071562
• MDR Text Key: 4828664
• Report Number: 3001845648-2014-00154
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2014
• Device Catalogue Number: ZIV6-35-125-7.0-120-PTX
• Device Lot Number: C781239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2014
• Event Location: Hospital
• Date Manufacturer Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2012
• 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 Outcome(s): Life Threatening
• Patient Age: 66 YR
• Patient Weight: 64