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

Catalog Number ZISV6-35-125-6.0-100-PTX

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Importer site establishment registration number: (b)(4).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

The surgeon was in place, ready to deliver the stent.He pushed on the red button but the delivery system did not work.No consequences on the patient.Yves will return the device."as per complaint form": after placement of the introducer, the doctor cross the lesion with a hydrophilic wire, make a pre dilatation and decided to place a zilver ptx no problem to advance the stent on the wire placed correctly the stent push the red button and start to turn the thumbwheel but no reaction on the tip of the system impression that the thumbwheel turn in nothing.The doctor decide to retrieve the system no action on the lesion but threat the proximal part of the sfa they was also a lesion and leave the proximal part without stent the patient come back in a few weeks to treat again the proximal part of the sfa.The doctor controlled under fluo if the stent was lost but still in the system.Update 10-july-18: confirmed that the doctor used the contralateral approach.

Manufacturer Narrative

Pma #(b)(4).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).Problem statement "the surgeon was in place, ready to deliver the stent.He pushed on the red button but the delivery system did not work.No consequences on the patient.Yes, will return the device.After placement of the introducer, the doctor cross the lesion with a hydrophilic wire, make a pre dilatation and decided to place a zilver ptx no problem to advance the stent on the wire placed correctly the stent push the red button and start to turn the thumbwheel but no reaction on the tip of the system impression that the thumbwheel turn in nothing the doctor decide to retrieve the system no action on the lesion but threat the proximal part of the sfa they was also a lesion and leave the proximal part without stent the patient come back in a few weeks to treat again the proximal part of the sfa.The doctor controlled under fluo(roscopy) if the stent was lost but still in the system update (b)(6) 2018: confirmed that the doctor used the contralateral approach" device evaluation: the zisv6-35-125-6.0-100-ptx device of lot number c1405241 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 0.035¿ diameter, terumo wire guide.The device was flushed prior to use.The stent was not deployed in the patient.The target location was severely calcified.Pre-dilation was conducted prior to stent deployment.The physician reported that the device thumbwheel malfunctioned.Resistance was not encountered when withdrawing the device from the patient.The distal part of the superficial femoral artery was treated with a stent a few weeks later, to complete the procedure.The customer confirmed that the complaint device was advanced over a contralateral approach.On evaluation of the returned device, crinkles were observed in the stent retraction sheath (srs) over a length between 63 and 105 cm from the strain relief.There was no damaged observed on the distal white tip.The device was flushed without issue.Resistance was encountered when passing a 0.035¿ diameter wire guide through the device.The device thumbwheel mechanism could be spun freely.The device was returned with the stent still loaded in the distal srs.The stent was released in the lab, and was undamaged.The stent length was 10cm.The device handle was opened, and the stent retraction wire was found to be separated from the stent retraction sheath.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 patient anatomy.From customer testimony, it is known that the target lesion was severely calcified.The difficult anatomy could have created resistance during deployment, and caused or contributed to the stent 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.There is no evidence to suggest that the customer did not follow the instructions for use.A capa (pr216126) has been initiated to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.Document review zisv6-35-125-6.0-100-ptx device of lot number c1405241 contains zvsp6-t-35-125-6.0-100-is of lot ch1336807.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.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 c1405241.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 another device a few weeks later.Complaints of this nature will continue to be monitored for potential emerging trends,.

Event Description

The surgeon was in place, ready to deliver the stent.He pushed on the red button but the delivery system did not work.No consequences on the patient.Yves will return the device."as per complaint form": after placement of the introducer, the doctor cross the lesion with a hydrophilic wire, make a pre dilatation and decided to place a zilver ptx no problem to advance the stent on the wire placed correctly the stent push the red button and start to turn the thumbwheel but no reaction on the tip of the system impression that the thumbwheel turn in nothing the doctor decide to retrieve the system no action on the lesion but threat the proximal part of the sfa they was also a lesion and leave the proximal part without stent the patient come back in a few weeks to treat again the proximal part of the sfa the doctor controlled under fluo if the stent was lost but still in the system (b)(6) 2018: confirmed that the doctor used the contralateral approach.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7689858
• MDR Text Key: 114038865
• Report Number: 3001845648-2018-00316
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352848
• UDI-Public: (01)10827002352848(17)190321(10)C1405241
• 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: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2019
• Device Catalogue Number: ZISV6-35-125-6.0-100-PTX
• Device Lot Number: C1405241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2018
• Event Location: Hospital
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention