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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/07/2022

Event Type  malfunction  

Event Description

Bohme et al 2021 - evaluation of stent angioplasty in the treatment of arteriosclerotic lesions of the common femoral artery.Patients treated with atherosclerotic lesions of the cfa between january 2008 and december 2018 were retrospectively selected from a prospective maintained database.Medical records, angiographies and endovascular procedures as well as duplex ultrasound examinations and ankle¿brachial index (abi) measurements were analyzed.Two-year target lesion revascularization (tlr) rate was the primary end point.Secondary end points were primary patency (restenosis was defined as stenosis with a peak systolic velocity ratio > 2.5 on color-flow duplex ultrasound measuring), overall procedural complication rate, the rate of ipsilateral cfa punctures during follow up, changes in rbc and ankle¿brachial index (abi), amputation rate and predictors on the reintervention rates.The procedural complication rate includes access site complications, target vessel perforation, outflow embolization and compartment syndrome.The time to tlr and the type of tlr (surgery or endovascular procedure) were documented.Zilver ptx stent used off label for evaluation of stent angioplasty in the treatment of arteriosclerotic lesions of the common femoral artery.This complaint was opened to capture one technical complication.Details of complications not provided in the literature paper and no adverse effects reported as a result of the technical failure.No adverse effects to the patient reported.

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

Supplement cancellation report being submitted due to receipt of clinical input on 08-feb-2023 confirming that the off-label use of zilver ptx device described in this literature paper were not attributed to the adverse events reported.Incident does not meet the criteria an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.This complaint was opened to capture one technical complication.Details of complications not provided in the literature paper and no adverse effects reported as a result of the technical failure.Updated description of event: bohme et al 2021 - evaluation of stent angioplasty in the treatment of arteriosclerotic lesions of the common femoral artery.Patients treated with atherosclerotic lesions of the cfa between january 2008 and december 2018 were retrospectively selected from a prospective maintained database.Medical records, angiographies and endovascular procedures as well as duplex ultrasound examinations and ankle¿brachial index (abi) measurements were analyzed.Two-year target lesion revascularization (tlr) rate was the primary end point.Secondary end points were primary patency (restenosis was defined as stenosis with a peak systolic velocity ratio > 2.5 on color-flow duplex ultrasound measuring), overall procedural complication rate, the rate of ipsilateral cfa punctures during follow up, changes in rbc and ankle¿brachial index (abi), amputation rate and predictors on the reintervention rates.The procedural complication rate includes access site complications, target vessel perforation, outflow embolization and compartment syndrome.The time to tlr and the type of tlr (surgery or endovascular procedure) were documented.This complaint was opened to capture one technical complication.Details of complications not provided in the literature paper and no adverse effects reported as a result of the technical failure.

Manufacturer Narrative

Pma/510(k) # p100022/s014.Incident does not meet the criteria an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.This complaint was opened to capture one technical complication.Details of complications not provided in the literature paper and no adverse effects reported as a result of the technical failure.

• 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: 16003863
• MDR Text Key: 308554675
• Report Number: 3001845648-2022-00897
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/07/2022
• Event Location: Hospital
• Date Manufacturer Received: 11/21/2022
• 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 Age: 71 YR
• Patient Sex: Male