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

Model Number	G38481
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #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 pending, a follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
Initial mdr is being submitted based on the device malfunction precedence: ¿deployment difficulty resulting in partial stent deployment'.As reported to customer relations: "either mid-deployment or after deployment, the handle broke apart.They did not ultimately use the stent, it was removed from patient.Everything of the device minus the stent available for return.".
Additional Manufacturer Narrative
Pma/510(k) #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).This follow up mdr is being submitted to cancel the initial mdr based on additional information received.A conservative approach was taken in initially assessing this complaint.After receiving additional information, it was found that the stent was not partially deployed.The device was defective out of the package and would not advance over wire.Never made it into the patient.Based on the information provided in this complaint, the risk will be established within the file.The most applicable fmea section is low risk.There is no health consequence / nuisance to patient or health user".No reporting malfunction precedence exists for this complaint event for this product family no adverse effects to the patient was reported as occurring.
Event or Problem Description
This follow up mdr is being submitted to cancel the initial mdr based on additional information received.As reported to customer relations: "either mid-deployment or after deployment, the handle broke apart.They did not ultimately use the stent, it was removed from patient.Everything of the device minus the stent available for return.".

• 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; national technology park; limerick
• MDR Report Key: 7577003
• Report Number: 3001845648-2018-00258
• Device Sequence Number: 1698138
• Product Code: NIU
• UDI-Device Identifier: 10827002384818
• UDI-Public: (01)10827002384818(17)190825(10)C1405962
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 06/07/2018

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 Model Number: G38481
• Device Catalogue Number: ZISV6-35-125-6-100-PTX
• Device Lot Number: C1405962
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/10/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1