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 Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6) was deploying a zilver ptx stent over a wire.He felt the red safety lock didn¿t feel right when he pressed it.When he started to roll the thumbwheel back to deploy the stent, it stopped and wouldn¿t deploy any further than 2 mm.Then a wire came out between the back of the thumbwheel and the device.

Event Description

A supplement report being submitted due to the completion of the investigation on 26jul2023.

Manufacturer Narrative

Pma 510k #p100022/s027.Device evaluation.The zilver ptx 35 drug-eluting stent device of unknown rpn and unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records.Prior to distribution all zilver ptx 35 drug-eluting 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 review.Historical data was not reviewed as the lot number is unknown.Instructions for use and/or label.It should be noted that the instructions for use (ifu0117) states the following: ¿do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.¿ there is no evidence to suggest that the customer did not follow the instructions for use.Image review.An image was not returned for evaluation.Root cause analysis.A definitive root cause could not be determined from the available information.Numerous attempts were made to obtain more information but unfortunately were unsuccessful.Should more information become available at a later stage, the file can be re-assessed and updated accordingly.A possible root cause could be attributed to patient anatomy.It is possible that if the patient¿s anatomy was difficult, this could have caused and/or contributed to resistance during advancement and/or deployment exerting excessive force on the outer sheath of the device.The resistance could have caused the red safety button to feel ¿not right¿ when pressed.It then, could have resulted in high deployment force to be used during the attempted deployment resulting in separation of the retraction wire from the srs which could have disrupted the deployment mechanism preventing complete stent deployment.It is also possible that if the approach used was contralateral and the bifurcation angle was tight, it could have contributed to the resistance during advancement and/or deployment resulting in separation of the retraction wire from the srs.Confirmation of complaint.Complaint is confirmed based on customer and/or rep testimony.Corrective action/correction.A capa (b)(4) has been implemented to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.The capa owner has been notified that this file may possible be linked but as the lot number is unknown, it cannot be confirmed at present.Should this information become available at a later stage, the file is to be re-assessed and the capa owner is to be notified.Summary of investigation.According to the initial reporter, the user was deploying a zilver ptx stent over a wire.He felt the red safety lock didn¿t feel right when he pressed it.When he started to roll the thumbwheel back to deploy the stent, it stopped and wouldn¿t deploy any further than 2 mm.Then a wire came out between the back of the thumbwheel and the device.Confirmed quantity of 1 device, confirmed used.According to the initial reporter, the patient is unknown.Numerous attempts were made to obtain the patient outcome but were unsuccessful.Should this information become available at a later stage, the file can be re-assessed and updated accordingly.Investigation findings conclude that a definitive root cause could not be determined.A possible root cause was attributed to patient anatomy.If the patient¿s anatomy was difficult, it could have caused and/or contributed to resistance during advancement and/or deployment exerting excessive force on the outer sheath of the device, resulting in separation of the retraction wire from the srs which could have disrupted the deployment mechanism preventing complete stent deployment.Also, if the approach used was contralateral and the bifurcation angle was tight, it could have contributed to the resistance during advancement and/or deployment.Complaint is confirmed based on customer and/or rep 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
• MDR Report Key: 16775238
• MDR Text Key: 313637054
• Report Number: 3001845648-2023-00252
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• 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: 03/22/2023
• Event Location: Hospital
• Date Manufacturer Received: 03/23/2023
• 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