MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Foreign Body Reaction (1868); No Information (3190)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Hoyt et al 2019 (zilver ptx) ¿ ¿assessment of vascular patency and inflammation with intravascular optical coherence tomography in patients with superficial femoral artery disease treated with zilver ptx stents¿ we used a 6f sheath and the contralateral retrograde access approach after obtaining initial access using either an 18-gauge needle or a 21-gauge micropuncture needle.The distal tip of the 6f sheath was placed in the common femoral artery (cfa) for imaging of the sfa.The target lesion was identified.Following peripheral angiography, patients with significant sfa disease (n60%) or total occlusions (100%) were treated with balloon angioplasty and stenting using the zilver ptx stent.Balloon sizing was based on 1:1 vessel ratio with the length covering from minimally diseased distal segment to minimally diseased proximal segment.After pre-dilatation, appropriate stent deployment was performed.Stent diameter was based on the manufacturer's guide-lines for vessel sizing (i.E., 1 to 2 mm stent: vessel oversizing).Stent length was based on covering the significant lesion completely from minimally diseased distal segment to minimally diseased proximal segment.An angiogram was performed to verify full deployment and expansion of the device; if there was incomplete expansion within the stent at any point along the lesion, post-deployment balloon dilatation was performed.Oct was performed to evaluate stent expansion and stent apposition as well as determination of intraluminal clot.Contralateral femoral ar-terial approach was used in 12 patients and ipsilateral retrograde popli-teal artery approach was used in 1 patient.1 patient had late-acquired stent malapposition.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation the zisv6 device of unknown lot number involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document based investigation was conducted.Document review as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that stent malapposition is listed as a known potential adverse event within the instructions for use (ifu0118-6).There is no evidence to suggest the user did not follow the ifu.Root cause review a definitive root cause could not be determined from the available information.Conditions.From the literature article it is known that late stent malapposition was linked to paclitaxel induced immune response.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up correction report is being submitted due to an update to medical device problem code (annex a) and health effect - impact code (annex f) and an update to the investigation conclusions.

Manufacturer Narrative

Device evaluation: the device evaluation could not be completed as the zisv6 device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Review historical data: historical data was not reviewed as the lot number is unknown.Instructions for use and/label it should be noted that stent malposition is listed as a known potential adverse event within the instructions for use.There is no evidence to suggest the user did not follow the ifu.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.From the literature article it is known that late stent malposition was linked to paclitaxel induced immune response.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony summary of investigation: according to the literature one patient had late-acquired stent malposition.Confirmed quantity of 1 device, confirmed used.There is no information from the article on patient outcome but as per clinical input there was potentially a need for some further intervention.Complaint confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 10820598
• MDR Text Key: 217947182
• Report Number: 3001845648-2020-00850
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 10/13/2020
• Supplement Dates FDA Received: 12/15/2021; 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 70 YR
• Patient Sex: Male