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

Model Number	G38489
Medical Device Problem Codes	Stretched (1601); Delivery System Failure (2905); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2018
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: "thumbwheel malfunctions during deployment", "deployment difficulties resulting in partial stent deployment" and ¿stent elongation", as reported to customer relations "the physician was deploying the stent and two-thirds of the stent deployed and the remainder would not deploy.It felt like the device locked.The physician took a kychoplasty kit and he broke the handle of the stent with kit and then pulled on the inner mechanism to finish deploying the stent.The final third of the stent stretched upon deployment.The physician then overlapped a second zilver ptx over the stretched part of the first stent to complete the procedure.The physician said it looked beautiful after the second stent was deployed.".
Event or Problem Description
This follow up report is being submitted to update the investigation results initial mdr submitted based on the device malfunction precedence: "thumbwheel malfunctions during deployment", " deployment difficulties resulting in partial stent deployment" and ¿stent elongation", as reported to customer relations "the physician was deploying the stent and two-thirds of the stent deployed and the remainder would not deploy.It felt like the device locked.The physician took a kychoplasty kit and he broke the handle of the stent with kit and then pulled on the inner mechanism to finish deploying the stent.The final third of the stent stretched upon deployment.The physician then overlapped a second zilver ptx over the stretched part of the first stent to complete the procedure.The physician said it looked beautiful after the second stent was deployed.".
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)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Problem statement: as reported to customer relations "the physician was deploying the stent and two-thirds of the stent deployed and the remainder would not deploy.It felt like the device locked.The physician took a kychoplasty kit and he broke the handle of the stent with kit and then pulled on the inner mechanism to finish deploying the stent.The final third of the stent stretched upon deployment.The physician then overlapped a second zilver ptx over the stretched part of the first stent to complete the procedure.The physician said it looked beautiful after the second stent was deployed." device evaluation: the zisv6-35-125-7-100-ptx device involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, the complaint device was advanced over an unknown wire guide, and was flushed prior to use.The stent was fully deployed.The patient¿s anatomy was not severely calcified or tortuous.Pre-dilation was not conducted prior to stent deployment.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Possible causes for this occurrence could include a difficult patient anatomy.A difficult anatomy could have created resistance during deployment, and caused or contributed to the thumbwheel mechanism malfunctioning.It can be noted that the customer did not describe the patient¿s anatomy as severely calcified or tortuous.However, as the device is not available for evaluation and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use.Document review: prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with this lot number.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk was determined to be low (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 7590698
• Report Number: 3001845648-2018-00263
• Device Sequence Number: 1775566
• Product Code: NIU
• UDI-Device Identifier: 10827002384894
• UDI-Public: (01)10827002384894(17)191212(10)C1474845
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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 Expiration Date: 12/12/2019
• Device Model Number: G38489
• Device Catalogue Number: ZISV6-35-125-7-100-PTX
• Device Lot Number: C1474845
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1