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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/26/2021

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # p100022/s014 (specific rpn is unknown).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Kwon et al 2022 - one-year outcomes of two different paclitaxel-eluting stents (zilver ptx and eluvia) for trans-atlantic inter-society consensus document (tasc) c/d obstructive femoropopliteal lesions.This study aimed to assess and compare the real-world outcomes of pes treatment, using either zilver ptx or eluvia pes, for patients with tasc type c/d femoropopliteal lesions following suboptimal angioplasty.The guidewire was passed through the occluded segment in an antegrade manner for 34 (92%) limbs, either in traluminally or subintimally.Re-entry devices were used in 47.6% of cases (10 limbs) when re-entry was not possible.The lesion passage was achieved using retrograde punctures in 3 (8%) cases.A mean number of 2.5 ± 0.69 stents (range, 1 - 3) was used in this study, covering 24.3 ± 7.96 cm (range, 6 - 35 cm).For 22 (59%) limbs, three stents were used.A pes with a diameter of 6 mm was used for 35 out of 37 (95%) limbs.A pes of 7 mm was used for the other two limbs (5%).The details of the intervention procedure are summarized in table 3.Overall, 56 zilver ptx stents and 36 eluvia stents were used in this study; different stents were not combined in the treatment of a single limb.No residual stenosis or in sufficient luminal gain was found following post-stent balloon dilatation.Figure 2 presents representative cases of pes for tasc c and tasc d lesions.S.Finally, 32 limbs of 29 patients were followed up within a one-year interval from the procedure.All patients visited the outpatient clinic at three, six, and 12 months after the procedure, and changes in their symptoms and complications were carefully observed.The abi was also measured at six and 12 months after the procedure.All patients received lifelong aspirin (100mg/day) and clopidogrel (75 mg/day) six weeks after the procedure.In case of in-stent restenosis or occlusion, the interval between the procedure and further treatment was recorded.All complications were classified according to the 2017 society of interventional radiology (sir) scale.This complaint was opened to capture adverse events observed in four limbs - they presented with acute thrombotic occlusion and underwent re-intervention within two weeks after the procedure.37 limbs of 34 patients (30 males and four females) with the mean age of 71.9±9.1 years (range, 53-90 years) male sex - 182/250 (72.8%).

Event Description

A supplemental report is being submitted due update to capture adverse events observed in two limbs as opposed to four limbs in original description on 14-mar- 23 and subsequent completion of the investigation on 17-mar-2023.

Manufacturer Narrative

Device evaluation: the device evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.With the information provided, a document-based investigation was conducted.This complaint is related to pr (b)(4) and was raised from the attached journal article (ref.Att kwon et al 2022 - one-year outcomes of two different paclitaxel-eluting stents (zilver ptx and eluvia) for trans-atlantic inter-society consensus document (tasc) c/d obstructive femoropopliteal lesions).This complaint was opened to capture acute thrombotic occlusion in 02 limbs that underwent re-intervention within two weeks after the procedure.Lab evaluation: the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document review prior to distribution all zilver ptx drug-eluting peripheral stent 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.Historical data was not reviewed as the lot number is unknown.It should be noted that occlusion is listed as a potential adverse event in the ifu0117.There is no evidence to suggest the user did not follow the ifu.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined.A possible root cause could have likely been attributed to patients¿ pre-existing condition.From the information available, in all patients, a stent was used for tasc c/d obstructive femoropopliteal lesions following suboptimal angioplasty.More than half of the patients had comorbidities, including hypertension and diabetes mellitus.Occlusion is 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.Summary: the complaint is confirmed based on customer testimony.The complaint was raised from the attached journal article kwon et al 2022 - one-year outcomes of two different paclitaxel-eluting stents (zilver ptx and eluvia) for trans-atlantic inter-society consensus document (tasc) c/d obstructive femoropopliteal lesions.According to the initial reporter, the patients underwent re-intervention within two weeks after the procedure.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
• MDR Report Key: 16003264
• MDR Text Key: 305684615
• Report Number: 3001845648-2022-00880
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/26/2021
• Event Location: Hospital
• Date Manufacturer Received: 11/21/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male