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

Catalog Number UNKNOWN

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Secondary endpoints are amputation-free survival (afs) and all-cause survival at 5 years.Amputation-free survival rate (59.2% vs 64.1% p=0.25).

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation the zisv6 devices of unknown lot number involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation ¿ n/a document review as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that ischemia requiring intervention ( bypass or amputation of toe, foot or leg) is listed as a known potential adverse event within the instructions for use (ifu0117-5).There is no evidence to suggest the user did not follow the ifu.Image review ¿ n/a root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing/underlying conditions.From the literature article it is known that patient pre-existing condition was femoropopliteal disease.The patient outcome is unknown.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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11937947
• MDR Text Key: 281411894
• Report Number: 3001845648-2021-00436
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• PMA/PMN Number: P100022
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• 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
• Event Location: Hospital
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention