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

Model Number	G38495
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional 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.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem 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.".
Additional 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 or Problem 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 or Problem 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.".
Additional 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
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8395048
• Report Number: 3001845648-2019-00091
• Device Sequence Number: 13512970
• Product Code: NIU
• UDI-Device Identifier: 10827002384955
• UDI-Public: (01)10827002384955(17)190801(10)C1401026
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019; 02/07/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/03/2019; 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1