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

Catalog Number ZISV6-35-125-8.0-40-PTX

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 08/09/2023

Event Type  Injury  

Event Description

14 july 2023 a patient underwent sfa on the ipsilateral side.9 august 2023 patient developed symptoms of a generalized rash and facial edema.Patch test results revealed a nickel allergy and steroids are being administered.Steroids are being administered.(4) prefix ziv6-ptx/zisv6-ptx: (4-1) are images of the device of procedure available?: no image available.(4-2) was the approach ipsilateral or contralateral?: ipsilateral side.(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?: unknown.(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) #: p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to medical affairs input being received on 06-mar-2024: severity +4 assigned.Supplemental report to include updates from device malfunction report 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: 17835481
• MDR Text Key: 324496526
• Report Number: 3001845648-2023-00743
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352978
• UDI-Public: (01)10827002352978(17)240909(10)C2001288
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-8.0-40-PTX
• Device Lot Number: C2001288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2023
• Event Location: Hospital
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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): Hospitalization