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

Catalog Number ZISV6-35-125-6.0-140-PTX

Device Problem Compatibility Problem (2960)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/28/2023

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #p100022/s026 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

24oct2023: zisv6-35-125-6.0-80-ptx (pr420369) and zisv6-35-125-6.0-140-ptx (pr420370) were placed in sfa.28oct2023: the patient developed a rash all over the body.An allergy to the metals used in zilver ptx or to paclitaxel was suspected.The patient was followed up.10nov2023: the patient recovered.The patient recovered on (b)(6) 2023.User¿s comment: i suspected an allergy to the metals used in zilver ptx or to paclitaxel.Sales rep's comment: same as the physician.[additional information] 4-1 are images of the device of procedure available? no image available 4-2 was the approach ipsilateral or contralateral? unknown 4-3 if contralateral, was the bifurcation angle tight? unknown 4-4 was pre-dilation performed ahead of placement of the stent? yes 4-5 was post-dilation performed after the placement of the stent? yes 4-6 details of the wire guide used (name, diameter, hyrdophyllic)? unknown 4-7 details of access sheath used (name, fr size, length)? unknown 4-8 was the device flushed before the procedure, as per ifu yes 4-9 what was the target location for the stent? sfa 4-10 was the patient's anatomy tortuous or calcified? no 4-11 was resistance encountered when advancing the wire guide or delivery system to the target location? no 4-12 how did the physician deal with this resistance? 4-13 did the stent delivery system cross the target location? yes.

Manufacturer Narrative

Pma/510(k) # (b)(4).Supplemental report is being submitted following a review of this complaint file.The severity level was updated to 'serious injury'.

Event Description

Supplemental report is being submitted following a review of this complaint file.The severity level was updated to 'serious injury'.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL 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: 18757638
• MDR Text Key: 336983447
• Report Number: 3001845648-2024-00064
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002354187
• UDI-Public: (01)10827002354187(17)250307(10)C2046062
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6.0-140-PTX
• Device Lot Number: C2046062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/28/2023
• Event Location: Hospital
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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