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

Catalog Number UNKNOWN

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Miura et al 2022 ¿ ¿cilostazol effectiveness in reducing drug- coated stent restenosis in the superficial femoral artery: the zero study¿.Participants underwent stenting with a zilver ptx stent and were treated with cilostazol (des with cilosta-zol group).In nearly all cases, a 6-french sheath was inserted into the femoral artery via the contralateral or ipsilateral approach.After 50¿100 iu/kg of heparin infusion, the lesion was crossed with a 0.014- or 0.035-inch guidewire.The lesion was dilated with a semicompliant or noncompliant scoring balloon.The recommended stent size was 1 mm greater than the diameter of the distal vessel before stent implantation.Post-dilatation was performed using a noncompliant balloon with a size equivalent to the diameter of the distal vessel.Major bleeding.

Manufacturer Narrative

Pma # - p100022/s027.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: the zilver ptx device involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file is related to (b)(4).This (b)(4) captures 03 cases of major bleeding.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Document review: prior to distribution all zisv6 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 was not reviewed as the lot number is unknown.It should be noted that the instructions for use list haemorrhage as a potential adverse event.There is no evidence to suggest the user did not follow the ifu.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.This list lists hematoma/haemorrhage as a potential adverse event.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined.A possible root cause could be attributed to known potential complications associated with the stent placement procedure and possible trauma to the anatomy during the procedure.As per clinical input ¿requires hospitalisation/prolong hospitalisation ¿ potentially although no details of incidents or outcomes are in the article¿ (ref.Att.Miura¿ clinical input.Msg).As previously noted, haemorrhage is listed as a potential adverse event in the ifu.Summary: the complaint is confirmed based on customer testimony.The complaint was raised from the literature article ¿miura et al 2022 ¿ ¿cilostazol effectiveness in reducing drug- coated stent restenosis in the superficial femoral artery: the zero study¿.According to the initial reporter, 03 patients experienced bleeding although no details of incidents or outcomes were mentioned in the article, complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 28-feb-2023.

• 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: 16003235
• MDR Text Key: 305684962
• Report Number: 3001845648-2022-00890
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 02/28/2023

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?: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2022
• 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 Outcome(s): Hospitalization