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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Possible pma 510k # p100022/s014; p100022/s026; p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Fransson, 2023, randomized clinical trial comparing drug eluting stent zilver ptx® versus bare metal stent zilver flex® for treatment of lesions in femoral and popliteal arteries in chronic limb threatening ischemia.Patients presenting with clti scheduled for endovascular treatment of fp lesions were randomly assigned by blinded envelopes 1:1 in a single blinded, parallel group design to des or bms after lesion crossing.Primary endpoints were target lesion revascularization (tlr) at 12 and 24 months and primary patency at 12 and 24 months.Secondary endpoints were technical success (ts), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (sae) at 24 month and survival at five years.This file was opened to capture the occurrence of predischarge retreatment in the des zilver ptx group.Require intervention/additional procedures.

Manufacturer Narrative

Possible pma 510k # p100022/s014; p100022/s026; p100022/s027.Supplemental report is being submitted as a cancellation report following confirmation that the events described in this pr 398900 are captured in pr 398902 (report reference number (b)(4).

Event Description

Supplemental report is being submitted as a cancellation report following confirmation that the events described in this pr 398900 are captured in pr 398902 (report reference number (b)(4).

• 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: 17161429
• MDR Text Key: 317453006
• Report Number: 3001845648-2023-00475
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: SW
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• 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?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/22/2023
• 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: 75 YR
• Patient Sex: Male