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 Improper or Incorrect Procedure or Method (2017)

Patient Problems Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 10/19/2022

Event Type  Injury  

Event Description

Park 2022, long coverage with drug-eluting stents is superior to spot coverage for long femoropopliteal artery disease: parade ii study in both groups, predilation of the target lesion was performed prior to stent implantation.In the long des group, stents were implanted to extend 10mm proximally and distally from the margins of the target lesion with a luminal narrowing of > 50%.When multiple stents were required, margins of the stents overlapped by at least 10mm.In the spot des group, stents were implanted only in those segments with residual stenosis > 30% or a flow limiting dissection after repeated predilation.In cases of an optimal result after predilation (without significant residual stenosis or flow-limiting dissection), a single stent was implanted to cover the most stenotic segment or the proximal stump of the occlusion before predilation.In both groups, zilver ptx with a diameter of 5¿7mm was used for stenting at the fp target lesions.Postdilation with an up to 10% oversized balloon was performed when the residual stenosis was > 30%.Clinically driven tlr was performed for restenotic lesions with both worsening symptoms and a > 0.15 decrement in abi.Survival free from tlr was significantly higher in the long des group than in the spot des group (figure 2b).This complaint will capture user error for spot stenting and target lesion revascularisation.Target lesion revascularization (tlr).Mean patient age was 70.9 ± 8.6 years, and the majority (82.5%) of study participants were male.

Manufacturer Narrative

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

Manufacturer Narrative

Sdevice evaluation user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.The complaint was raised from the attached article ¿park 2022, long coverage with drug-eluting stents is superior to spot coverage for long femoropopliteal artery disease: parade ii study¿ and is related to pr (b)(4) (emdr ref.- 3001845648-2022-00899 ) , pr (b)(4) (emdr ref.-3001845648-2022-00900) ,pr (b)(4) (emdr ref.3001845648-2022-00901), pr (b)(4) ( emdr ref.- 3001845648-2022-00902 ) , pr (b)(4) ( emdr ref.- 3001845648-2022-00903 ) and pr (b)(4) ( emdr ref.- 3001845648-2022-00904 ).This complaint was opened to capture 15 cases of user error for spot stenting and target lesion revascularisation.The spot stenting method used in this study involved the placing of stents at isolated selected positions along the lesion.The zilver ptx devices of unknown rpns and unknown lot numbers involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document-based investigation was conducted.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all zilver ptx 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.Ifu/label review: instructions for use (ifu0117) states the following: ¿if placements of multiple stents are required in a patient, to cover the length of the lesion, the following recommendations should be considered: stents placed in tandem must overlap to allow for complete coverage of the lesion.¿ there is evidence to suggest the user did not follow the ifu.It should also be noted that instructions for use (ifu0117) lists occlusion as a potential adverse event.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of user error was identified from the available information.From the information available, it is known that the user employed a spot stenting method.This involves stenting only certain parts of the vessel and lesion (the most narrowest), leaving other areas untreated.Instruction for use states that when multiple stents are placed, they should overlap and cover the length of the lesion.It should also be noted that instructions for use (ifu0117) lists occlusion as a potential adverse event.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the initial reporter, in the spot des group, stents were implanted only in those segments with residual stenosis > 30% or a flow limiting dissection after repeated predilation.The complaint was raised from the attached article.Confirmed quantity of 15 devices, confirmed used.According to the initial reporter, there was 15 cases of tlr in the long des group, would have likely required intervention/additional procedures to prevent permanent impairment/damage.Investigation findings conclude a definitive root cause was established.The user has not complied with the requirements of the ifu.From the information available, it is known that the lesion was stented at selected isolated locations and the ifu states that when multiple stents are placed, they should overlap and cover the length of the lesion.Instructions for use also lists occlusion as a potential adverse event.The complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This report is being submitted due to the completion on the investigation on the 27-jul-2023.

• 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: 16688838
• MDR Text Key: 312767600
• Report Number: 3001845648-2023-00219
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue 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: 10/19/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 03/16/2023
• Supplement Dates FDA Received: 08/24/2023
• 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: 71 YR
• Patient Sex: Male