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

Model Number G38489

Device Problem Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s014.Problem statement "the thumbwheel froze during the stent delivery; the device was partially deployed at this time.The handle had to be broke open and the wire was cut to manipulate the device to deploy.The stent was not able to be deployed in the target site, so an additional device (g38490) was placed to cover the targeted area." device evaluation the zisv6-35-125-7-100-ptx device of lot number c1425220 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The customer was contacted to request additional information and to return the device.At the time of the investigation, the device and the information are not yet available.The investigation will be updated once the device and information are provided.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 calcified or tortuous patient anatomy could have caused or contributed to the malfunction of the deployment mechanism.This could prevent the stent deploying fully.However, as the device and information are not yet available, 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: zisv6-35-125-7-100-ptx device of lot number c1425220 contains zvsp6-t-35-125-7-100-is (zilver ptx) of lot ch1396189.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 lot number c1425220.A temporary failure mode of "deployment difficult" has been assigned.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk will be assessed for this complaint once the device has been returned and evaluated, and once completed the investigation will be updated with the risk details.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The procedure was completed with another device.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Initial mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment".The thumbwheel froze during the stent delivery; the device was partially deployed at this time.The handle had to be broke open and the wire was cut to manipulate the device to deploy.The stent was not able to be deployed in the target site, so an additional device (g38490) was placed to cover the targeted area.

Event Description

This follow up mdr is being submitted to inform the fda that the device has been returned and is currently being evaluated.A follow up report will be sent within 30 days.Initial mdr submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment".The thumbwheel froze during the stent delivery; the device was partially deployed at this time.The handle had to be broke open and the wire was cut to manipulate the device to deploy.The stent was not able to be deployed in the target site, so an additional device (g38490) was placed to cover the targeted area.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to mfr site as follows: importer site contact and address: (b)(6).Importer site establishment registration number: (b)(4).Pma/510(k)#: p100022/s014.This follow up mdr is being submitted to inform the fda that the device has been returned and is currently being evaluated.A follow up report will be sent within 30 days.

Event Description

This follow up mdr is being submitted to update the investigation details.Initial mdr submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment" and "retraction wire separated from stent retraction sheath." the thumbwheel froze during the stent delivery; the device was partially deployed at this time.The handle had to be broke open and the wire was cut to manipulate the device to deploy.The stent was not able to be deployed in the target site, so an additional device (g38490) was placed to cover the targeted area.

Manufacturer Narrative

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).Pma/510(k) # p100022/s014.Problem statement "the thumbwheel froze during the stent delivery; the device was partially deployed at this time.The handle had to be broke open and the wire was cut to manipulate the device to deploy.The stent was not able to be deployed in the target site, so an additional device (g38490) was placed to cover the targeted area." device evaluation.The zisv6-35-125-7-100-ptx device involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.From customer testimony, it is known that the complaint device was advanced over a 0.014¿ diameter, boston scientific thruway wire guide.The device was flushed prior to use.The patient¿s anatomy was calcified.Pre-dilation was conducted prior to stent deployment.The target location for the device was in the patient¿s superficial femoral artery (sfa).The device was advanced via a contralateral approach.There are no images of the procedure available.The aortic bifurcation was not unusually tight or steep.Resistance was not encountered when advancing the complaint device or wire guide to the target lesion.The details of the access sheath are not known.The device related to this occurrence underwent a laboratory evaluation on the 12th april 2018.On evaluation of the returned device, it was noted that the device was returned disassembled and without the stent.There was fish mouth damage on the distal white tip.The retraction wire was found to be separated from the stent retraction sheath.The device pulley was missing.Faint crinkles were observed on the distal stent retraction sheath and stability sheath with a 8mm pitch.Complaint is confirmed as the failure was verified in the laboratory.The retraction wire was found to be separated from the stent retraction sheath.Possible causes for this occurrence could include a difficult patient anatomy, or the use of a non-recommended wire guide.A calcified or tortuous patient anatomy could have created resistance during deployment.The non-recommended wire could have provided insufficient support during deployment.These factors could have caused or contributed to the retraction wire separating from the stent retraction sheath.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.It can be noted that as per the product instruction for use: precautions: ¿a 0.035 inch (0.89mm) diameter wire guide should be used during tracking, deployment and removal in order to ensure adequate support of the system¿ a capa has been initiated to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.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 complaint is confirmed as the failure was verified in the laboratory.The retraction wire was found to be separated from the stent retraction sheath.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.The procedure was completed with another device.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 7384810
• MDR Text Key: 104156084
• Report Number: 3001845648-2018-00150
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384894
• UDI-Public: (01)10827002384894(17)190911(10)C1425220
• 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: 05/09/2018

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
• Device Operator: Health Professional
• Device Model Number: G38489
• Device Catalogue Number: ZISV6-35-125-7-100-PTX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/05/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 04/12/2018; 05/09/2018
• Supplement Dates FDA Received: 05/09/2018; 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1