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 Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422)

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 micro-puncture 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 arterial approach was used in 12 patients and ipsilateral retrograde popliteal artery approach was used in 1 patient.1 patient was not properly imaged due to machine malfunction as well as the presence of total occlusion at follow-up that disqualified the patient from quantitative analysis.

Manufacturer Narrative

Device evaluation: the unknown 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 occlusion is listed as a known potential adverse event within the instructions for use (ifu0117-5).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.A possible root cause could be attributed to patient pre-existing/underlying conditions.From the literature article it is known that patient pre-existing conditions included claudication and/or critical limb ischemia with severe femoral popliteal disease.Occlusion is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by obstruction to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Summary: complaint is confirmed based on customer testimony.The outcome of the patient is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Final mdr being submitted due to completion of the investigation on 29-sept-21.

Manufacturer Narrative

Correction mdr being submitted due to correction to annex a code on 27-jul-2022 - a1409 to be changed to a24.Device evaluation the unknown 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 occlusion is listed as a known potential adverse event within the instructions for use (ifu0117-5).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.A possible root cause could be attributed to patient pre-existing/underlying conditions.From the literature article it is known that patient pre-existing conditions included claudication and/or critical limb ischemia with severe femoral popliteal disease.Occlusion is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by obstruction to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Summary complaint is confirmed based on customer testimony.The patient's outcome is unknown; however, clinical input suggests some form of intervention would likely be required as a result of this event.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Correction mdr being submitted due to correction to annex a code on (b)(6) 2022 - a1409 to be changed to a24.

• 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
• MDR Report Key: 10820581
• MDR Text Key: 217929264
• Report Number: 3001845648-2020-00848
• 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: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: 09/29/2021
• Event Location: Hospital
• Date Manufacturer Received: 10/13/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male