MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

Catalog Number UNKNOWN

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

Patient Problems Ischemia (1942); Pain (1994); Obstruction/Occlusion (2422); Tissue Breakdown (2681)

Event Type  Injury  

Event Description

Zamani et al 2020 ¿ (zilver ptx)¿outcomes after endovascular stent placement for long-segment superficial femoral artery lesions¿.All cases were either primarily stented or followed angioplasty when the degree of residual stenosis exceeded 50% or when a flow-limiting dissection was identified.Technical success was defined as re-establishment of sfa patency with flow across the target lesion with less than 30% re-sidual stenosis on completion angiography.The des (n=57) was self-expanding nitinol stents with a polymer-free pacli-taxel coating (zilver ptx; cook medical, blooming-ton, in).Target lesion revascularization.Symptoms at stent occlusion included claudication (4), rest pain or tissue loss (6) and acute limb ischemia (ali) (1).Stented lesions collectively required 11 endovascular and 2 open revasculatization attempts.The vast majority of both endovascular and open reinterventions occurred within 18 months of initial stent placement.Among the cases with ali, 8 (47% of overall cohort) required an open arterial bypass of the target lesion, all of whom were in patients initially treated with cs.

Manufacturer Narrative

Common device name: niu stent, superficial femoral artery, drug-eluting.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 13151116
• MDR Text Key: 288488801
• Report Number: 3005580113-2022-00007
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2021,01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2021
• 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: 66 YR
• Patient Sex: Male