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

Model Number G38482

Device Problem Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.

Event Description

Initial mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment¿.As reported to customer relations: "during an unknown procedure the zilver ptx 35 drug-eluting stent, g38482, was used.The stent was barely out and the thumbwheel kept turning but the stent would not continue to come out.An.035 amplatz wire was being used with the device.The physician removed this device and used another of the same device to continue the procedure.The district manager was present during this case and confirmed there was no harm to the patient.".

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).Pma/510(k) #p100022/s014.Problem statement: "as reported to customer relations: "during an unknown procedure the zilver ptx 35 drug-eluting stent, g38482, was used.The stent was barely out and the thumbwheel kept turning but the stent would not continue to come out.An.035 amplatz wire was being used with the device.The physician removed this device and used another of the same device to continue the procedure.The district manager was present during this case and confirmed there was no harm to the patient." per district manager 23feb2018: " we[the customer] were up and over the aortic bifurcation and the bifurcation was moderate.Physician stated he had to push the catheter a lot to get it in place." th 26feb2018.¿ device evaluation: the zisv6-35-125-6-120-ptx device of lot number c1422672 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 0.035¿ diameter amplatz wire guide.The stent wasn¿t deployed.The device was flushed prior to use.The target site was calcified and iliacs were tortuous.The pre-dilatation was conducted prior to stent deployment.The stent did not deploy in the patient.The device related to this occurrence underwent a laboratory evaluation on the 22nd february 2018.On evaluation of the returned device, it was observed that the device was returned with stent still loaded in stent retraction sheath (srs).It was noted that 10.5 cm of the stent was still in the stent retraction sheath.There was evidence of stent fracture.Crinkles/kinks were observed in distal end of the stent retraction sheath.It was noted that the kink was 61.5 cm from strain relief.It was possible to flush the device, but a 0.035¿ diameter wire guide would not pass through the kink.The device handle was opened and the thumbwheel was tested, however it was unable to deploy the stent.It was observed that the retraction wire separated from stent retraction sheath.Proximal inner was found to be damaged/separated at first laser cut.Damage was observed on the distal white tip.On the evaluation of the returned device it was noted that there was evidence of stent fracture, therefore additional information was requested.From customer testimony, it is known that the physician went up and over the aortic bifurcation and the bifurcation was moderate.Physician stated he had to push the catheter a lot to get it in place.The customer confirmed that there was possibility that the stent got fractured while the device was removed or on the back table.Customer confirmed that they did not notice a fracture during the procedure.Complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was found to be separated from the stent retraction sheath (srs), preventing stent deployment.Sustaining engineering reviewed the details of the complaint, and the results of the lab evaluation.Possible root causes for this occurrence could include calcified and tortuous anatomy.Patient's anatomy could have possibly caused damage to distal tip, stent retraction sheath (srs) and proximal inner component.This could also have lead to resistance during deployment, possibly causing or contributing to the retraction wire separation.However, as 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.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 stent retraction wire was found to be separated from the stent retraction sheath (srs).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.

Event Description

This follow up report is being submitted to update the investigation results.Initial mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment¿.As reported to customer relations: "during an unknown procedure the zilver ptx 35 drug-eluting stent, g38482, was used.The stent was barely out and the thumbwheel kept turning but the stent would not continue to come out.An.035 amplatz wire was being used with the device.The physician removed this device and used another of the same device to continue the procedure.The district manager was present during this case and confirmed there was no harm to the patient.".

• 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: 7280185
• MDR Text Key: 100538166
• Report Number: 3001845648-2018-00067
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)190915(10)C1422672
• 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
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/22/2018
• Event Location: Hospital
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1