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 Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #p100022/s014 (b)(4).Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

This initial mdr is being submitted based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿ and "deployment difficulty resulting in partial stent deployment" per rep - as they were rolling back the thumbwheel, the sheath would not fully retract and the device would not deploy.They successfully completed the procedure with a drug coated balloon.Update 01feb2018 - per rep - i was able to talk with dr.(b)(6) about the case.Patient had a steep bifurcation with a large chunk of calcium at the proximal portion.He used csi to cut through it.With the viper wire down, he put the 6x120 zptx to cover isr toward the distal sfa.A few clicks and the retractable sheath quit moving.He removed the viper and placed an 0.035 down, removed the partially deployed zptx in its entirety, and utilized a dcb instead.

Manufacturer Narrative

Pma/510(k) #p100022/s014.(b)(4).Exemption number: e2016031.(b)(4).Problem statement: "per rep - as they were rolling back the thumbwheel, the sheath would not fully retract and the device would not deploy.They successfully completed the procedure with a drug coated balloon.Update 01feb2018 - per rep - i was able to talk with dr.(b)(6) about the case.Patient had a steep bifurcation with a large chunk of calcium at the proximal portion.He used csi (cardiovascular systems inc.) to cut through it.With the viper wire down, he put the 6x120 zptx to cover isr (in stent restenosis) toward the distal sfa (superficial femoral artery).A few clicks and the retractable sheath quit moving.He removed the viper and placed a 0.035 down, removed the partially deployed zptx (zilver ptx) in its entirety, and utilized a dcb (drug coated balloon) instead." device evaluation: the zisv6-35-125-6-120-ptx device of lot number c1435490 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.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, viper wire guide.The device was flushed prior to use.The patient¿s anatomy was calcified and had a steep bifurcation.The customer was contacted to confirm if any portion of the stent was implanted in the patient.The investigation will be updated once the information has been provided.The device related to this occurrence underwent a laboratory evaluation on the 22 february 2018.On evaluation of the returned device, crinkles were observed in the distal stent retraction sheath (srs).The device was returned with a portion of the stent still loaded into the srs.The device was flushed, and a 0.035¿ diameter wire guide was advanced through the device without resistance.There was no damage noted on the distal white tip.The stent retraction wire was seen exiting the device handle.The handle was opened, and the stent retraction wire was found to be separated from the stent retraction sheath.The stent portion was released in from the srs in the lab, and was measured as 9.2 cm long.There was evidence of stent fracture.The pet (polyethylene terephthalate) coating on the proximal end of the proximal inner component was found to be damaged.However, this could have occurred as the sheaths were disassembled in the lab.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.Possible causes for this occurrence could include the use of a non-recommended wire guide, or the calcified and tortuous anatomy.From customer testimony, the device was advanced over a 0.014¿ diameter wire guide, and through a calcified anatomy with a steep bifurcation.These factors could have damaged the distal stent retraction sheath.The damage could have created resistance during deployment, which could have caused or contributed to the stent retraction wire separating from the stent retraction sheath.It is not yet known how the stent was fractured.However, as the information has not yet been provided, and 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 (b)(4) 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 lot number c1435490.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.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 a drug coated balloon.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 details.Device malfunction reporting precedence for this device family for the issue of "retraction wire separates from stent retraction sheath" and "stent fracture" also apply.Initial mdr is submitted based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿ and "deployment difficulty resulting in partial stent deployment".Per rep - as they were rolling back the thumbwheel, the sheath would not fully retract and the device would not deploy.They successfully completed the procedure with a drug coated balloon.Update 01feb2018 - per rep - i was able to talk with dr.(b)(6) about the case.Patient had a steep biforcation with a large chunk of calcium at the proximal portion.He used csi to cut through it.With the viper wire down, he put the 6x120 zptx to cover isr toward the distal sfa.A few clicks and the retractable sheath quit moving.He removed the viper and placed an 0.035 down, removed the partially deployed zptx in its entirety, and utilized a dcb instead.

• 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: 7302224
• MDR Text Key: 101577244
• Report Number: 3001845648-2018-00089
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)191010(10)C1435490
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• 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: 02/01/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR