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

Model Number G38495

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

510(k) number: p100022/s014.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

There are three files related to this incident, this file was created to capture the third device.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿.As reported to customer relations, "products failed to deploy correctly.Deployment issue.Coaxial system didn¿t move, seemed very tight while scrolling back.While pulling first system out stent started coming out of catheter.Patient was ok.A stent was fracture and broke and left in patient, doctor angioplastied stent to wall in common femoral.No adverse effects.The second and third device felt tightness upon scrolling back, decided to remove device completely.Safely removed device, patient fine, no additional products.".

Manufacturer Narrative

510(k) number: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.This report is being submitted as a cancellation report.Device evaluation confirmed that it was possible to deploy the stent using the thumbwheel.The events do not meet the criteria of an fda mdr report.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This report is being submitted as a cancellation report following device evaluation.There are three files related to this incident, this file was created to capture the third device.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿.As reported to customer relations, "products failed to deploy correctly.Deployment issue.Coaxial system did not moved seem very tight while scrolling back.While pulling first system out stent started coming out of catheter.Patient was ok.A stent was fracture and broke and left in patient, doctor angioplastied stent to wall in common femoral.No adverse effects.The second and third device felt tightness upon scrolling back, decided to remove device completely.Safely removed device, patient fine, no additional products.".

Event Description

There are three files related to this incident, this file was created to capture the third device.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿.As reported to customer relations, "products failed to deploy correctly.Deployment issue.Coaxial system didn¿t moved seem very tight while scrolling back.While pulling first system out stent started coming out of catheter.Patient was ok.A stent was fracture and broke and left in patient, doctor angioplastied stent to wall in common femoral.No adverse effects.The second and third device felt tightness upon scrolling back, decided to remove device completely.Safely removed device, patient fine, no additional products.".

Manufacturer Narrative

510(k) number: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• 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
• MDR Report Key: 8395048
• MDR Text Key: 138146082
• Report Number: 3001845648-2019-00091
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384955
• UDI-Public: (01)10827002384955(17)190801(10)C1401026
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: G38495
• Device Catalogue Number: ZISV6-35-125-8-40-PTX
• Device Lot Number: C1401026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1