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

Catalog Number ZISV6-35-125-7.0-140-PTX

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

Patient Problems Obstruction/Occlusion (2422); Thromboembolism (2654); Thrombosis/Thrombus (4440)

Event Date 08/25/2022

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

(b)(6) 2021: a ranger paclitaxel-coated pta balloon catheter (boston scientific /lot#:unknown) was used for the distal of the left shallow femoral artery.Zilver ptx was implanted in the proximal.(b)(6) 2022: eluvia (boston scientific /lot#:unknown) was deployed from the right shallow femoral artery to the popliteal artery.In.Pact (medtronic /lot#: unknown) was also used.Patient outcome: (b)(6) 2022: thrombotic occlusion was observed from ziliver ptx deployment area to eluiva deployment area in the shallow femoral artery.(b)(6) 2022: the target limb was amputated as a treatment.(b)(6) 2022: the patient died.The cause of death was multiple cerebral infarction, unrelated to the amputation of the target limb.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 10-jan-2024.

Manufacturer Narrative

Pma/510(k) # p100022/s014.Device evaluation: the zisv6-35-125-7.0-140-ptx device of lot number unknown involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records review: prior to distribution all zilver ptx devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data review: as per (b)(4) rev 027 table 1 historical data review is not required for complaint category "adverse event".Instructions for use and label: the japanese packaging insert c-ci1502m06 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.It should be noted that japanese packaging insert c-ci1502m06 lists the following as potential adverse events: atheroembolization (blue toe syndrome: poor circulation to toe and feet due to microvascular occlusion).Arterial thrombosis, stent thrombosis.Embolism.Ischemia requiring intervention (bypass or amputation of toe, foot, or leg).Occlusion.Restenosis or occlusion of the stented artery.There is no evidence to suggest the user did not follow the japanese packaging insert.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patient pre existing conditions which from the available information included hypertension, transient ischemic attack, coronary artery disease, myocardial infarction, congestive heart failure and had been previously treated with percutaneous coronary angioplasty and percutaneous lower extremity angioplasty.It should also be noted that arterial thrombosis, stent thrombosis, embolism and occlusion are listed as known potential adverse events within the japanese packaging insert.Confirmation of complaint: complaint is confirmed based on customer testimony and/or rep testimony.Summary of investigation: according to the initial reporter, a ranger paclitaxel-coated pta balloon catheter (boston scientific) was used in the distal left shallow femoral artery.A zilver ptx was implanted in the proximal.Thrombotic occlusion was observed from zilver ptx deployment area to eluiva deployment area in the shallow femoral artery.The target limb was amputated as a treatment.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, thrombotic occlusion was observed in the shallow femoral artery and the target limb was amputated as a treatment.Investigation findings conclude a possible root cause of the patients pre existing conditions.As previously noted, atheroembolization , arterial thrombosis, stent thrombosis, embolism, ischemia requiring intervention (bypass or amputation of toe, foot, or leg), occlusion and restenosis or occlusion of the stented artery are all listed as potential adverse events in the japanese packaging insert.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 17316450
• MDR Text Key: 319280699
• Report Number: 3001845648-2023-00550
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-7.0-140-PTX
• 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: 08/25/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 01/26/2024
• 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: 96 YR
• Patient Sex: Female