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

Catalog Number	ZISV6-35-125-7-80-PTX
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter, the physician was attempting to place a 7mm/80mm zilver ptx in a patient¿s transverse sinus (off of ifu).When scrolling the thumb wheel back to deploy the stent the wheel stopped turning leaving half of the stent deployed and half of the stent undeployed.I was called and with the situation described i instructed them to take apart the handle and pull on the wire inside to finish deploying the stent.After that did not work, they facetimed me and i saw that the sheath looked to be severed.That was unknown before i instructed them to pull the wire inside of the handle.They asked me to come in to try to help.While thirty minutes out from the hospital i asked for an update, and they said vascular surgery came by and pulled it out.The sheath came out with all the pieces attached but broke the stent.Half of the stent is retained in the patient with no issue as of this moment.When i looked at the device, the outer sheath was broken, the inner piece that retracts was broken and unwound, and the nose cone was still attached with pieces of the broken stent.They have the device to send back but i was told the hospital must look at the device first before it¿s turned over to me.I said it would be best if we looked at it first, but they kept it.I was told that i can have it to send in when they are done.Things to note: they tried to deploy the stent without a wire through the system there was an 8fr tracstar ldp catheter that the zilver ptx was placed through, not a sheath.The inner lumen on the box of this catheter reads 2.24mm (i have a picture of the box) the physician noted that the red safety was very hard to depress and once depressed a very loud click was heard.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 20358219
• Report Number: 3005580113-2024-00069
• Device Sequence Number: 15274923
• Product Code: NIU
• UDI-Device Identifier: 10827002384887
• UDI-Public: (01)10827002384887(17)260617(10)C2206393
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2024
• Report Date (Section F): 10/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2026
• Device Catalogue Number: ZISV6-35-125-7-80-PTX
• Device Lot Number: C2206393
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/09/2024
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• Date Device Manufactured: 08/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/03/2024