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

Catalog Number ZISV6-35-125-7.0-140-PTX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Ipsilateral approach was gained to treat a lesion in the sfa.After disengaging the safety lock of zisv6-35-125-7.0-140-ptx/ lot c1579537, the user rotated the thumbwheel but the retraction sheath did not move.According to the user, he did not hold the boundary between the stability sheath and the retraction sheath while rotating the thumbwheel.(see "(b)(4) boundary between the stability sheath and the retraction sheath.Jpg") zisv6-35-125-6.0-140-ptx lotc1581675 was used instead and the procedure was completed.

Event Description

Ipsilateral approach was gained to treat a lesion in the sfa.After disengaging the safety lock of zisv6-35-125-7.0-140-ptx/ lot c1579537, the user rotated the thumbwheel but the retraction sheath did not move.According to the user, he did not hold the boundary between the stability sheath and the retraction sheath while rotating the thumbwheel.Zisv6-35-125-6.0-140-ptx lotc1581675 was used instead and the procedure was completed.1 are images of the device of procedure available? no.2-a was the approach ipsilateral or contralateral? ipsilateral.2-b if contralateral, was the bifurcation angle tight? asku.3 was pre-dilation performed ahead of placement of the stent? yes.4 was post-dilation performed after the placement of the stent? yes.5 details of the wire guide used (name, diameter, hyrdophyllic)? asahi intecc / astato 0.014inch 300cm.6 details of access sheath used (name, fr size, length)? terumo / destination 6fr 35.7 was the device flushed before the procedure, as per ifu yes.8 what was the target location for the stent? asku.9 was the patient's anatomy tortuous or calcified? no.10-a was resistance encountered when advancing the wire guide or delivery system to the target location? no.10-b how did the physician deal with this resistance? asku.11 did the stent delivery system cross the target location? yes.Questions below are being asked to the rep.Was pre dilatation conducted before stent deployment? yes.Was the delivery system kinked or twisted during deployment? no.Thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? yes.Thumbwheel only ¿ was the retraction sheet being held during deployment? no.

Manufacturer Narrative

Device evaluation: the zisv6-35-125-7.0-140-ptx device of lot number c1579537 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Document review prior to distribution zisv6-35-125-7.0-140-ptx devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for zisv6-35-125-7.0-140-ptx of lot number c1579537 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c1579537.It should be noted that the instructions for use (ifu0117-4) states the following: ¿precautions a 0.89 mm (0.035 inch) wire guide should be used during tracking, deployment, and removal to ensure adequate support of the system.If hydrophilic wire guides are used, they must be kept fully activated.¿ there is evidence to suggest the user did not follow the ifu.The japanese packaging insert (c-ci1502m02) supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause review: a definitive root cause could be attributed to the use of a non-recommended wire guide with the device.From the information provided it is known that a 0.014¿ wire guide was used with the device.It is possible that the use of a non-recommended wire guide resulted in insufficient device support during advancement.It is likely that the insufficient support resulted in separation of the retraction wire from the stent retraction sheath (srs) during attempted deployment.This is confirmed from the additional information as it is known that the thumbwheel spun freely without stent release.This would have resulted in the inability for the user to deploy the stent in the patient.Summary: complaint is confirmed as the failure was verified in the laboratory.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 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: 9917124
• MDR Text Key: 198106169
• Report Number: 3001845648-2020-00197
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002354217
• UDI-Public: (01)10827002354217(17)201121(10)C1579537
• Combination Product (y/n): N
• PMA/PMN Number: P100022
• 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: 04/26/2020

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 Expiration Date: 11/21/2020
• Device Catalogue Number: ZISV6-35-125-7.0-140-PTX
• Device Lot Number: C1579537
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1