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

Catalog Number ZISV6-35-125-5.0-80-PTX

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The product is implanted in the patient, but when the stent was deployed it remained wrinkled and undeployed partially.Are images of the device of procedure available? yes.Was the approach ipsilateral or contralateral? ipsilateral anterograde.If contralateral, was the bifurcation angle tight? was pre-dilation performed ahead of placement of the stent? yes.Was post-dilation performed after the placement of the stent? yes.Details of the wire guide used (name, diameter, hyrdophyllic)? ¿ cxi sobre roadrunner 0,035.Details of the access sheath used (name, fr size, length)? 6fr corto 15 cms.Was the device flushed before the procedure, as per ifu yes.What was the target location for the complaint device? femoral superficial.Was the patient's anatomy tortuous or calcified? yes.Was resistance encountered when advancing the wire guide or delivery system to the target location? yes, thrombosed a big segment of femoral superficial.How did the physician deal with this resistance? did the stent delivery system cross the target location? yes, but he needed another stent no farmacoactivo for no stock of zilver of this measure.What artery was the stent placed in? femoral superficial.Is the patient known to be covid-19 positive? no.

Event Description

This follow-up supplemental report is being submitted due to the receipt of image review on 23-oct-2020.Image review received 23-oct-2020 as follows: "deployment of zisv6-35-125-5.0-80-ptx stent to a length of 40.93mm is confirmed.The stent was deployed just after successful deployment of another zilver ptx stent in the distal sfa.The first stent was likely deployed with the stability sheath inside the access sheath.The concertinaed stent was likely deployed with the stability sheath outside the access sheath.This would have advanced the delivery system during deployment causing the stent to concertina.The advancement would have been particularly unexpected given normal deployment of the first stent." initial report details: the product is implanted in the patient, but when the stent was deployed it remained wrinkled and undeployed partially.1.Are images of the device of procedure available? yes, attached.2.Was the approach ipsilateral or contralateral? ipsilateral anterograde.3.If contralateral, was the bifurcation angle tight? 4.Was pre-dilation performed ahead of placement of the stent? yes.5.Was post-dilation performed after the placement of the stent? yes.6.Details of the wire guide used (name, diameter, hyrdophyllic)? ¿ cxi sobre roadrunner 0,035.7.Details of the access sheath used (name, fr size, length)? 6fr corto 15 cms.8.Was the device flushed before the procedure, as per ifu yes.9.What was the target location for the complaint device? femoral superficial.10.Was the patient's anatomy tortuous or calcified? yes.11.Was resistance encountered when advancing the wire guide or delivery system to the target location? yes, thrombosed a big segment of femoral superficial.How did the physician deal with this resistance? 12.Did the stent delivery system cross the target location? yes, but he needed another stent no farmacoactivo for no stock of zilver of this measure.13.What artery was the stent placed in? femoral superficial.14.Is the patient known to be covid-19 positive? no.

Manufacturer Narrative

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

Event Description

Supplemental report being submitted to update the report classification from malfunction to serious injury following clinical input received on 11-jan-2021.The product is implanted in the patient, but when the stent was deployed it remained wrinkled and undeployed partially.1.Are images of the device of procedure available? yes, attached.2.Was the approach ipsilateral or contralateral? ipsilateral anterograde.3.If contralateral, was the bifurcation angle tight? 4.Was pre-dilation performed ahead of placement of the stent? yes.5.Was post-dilation performed after the placement of the stent? yes.6.Details of the wire guide used (name, diameter, hyrdophyllic)? ¿ cxi sobre roadrunner 0,035.7.Details of the access sheath used (name, fr size, length)? 6fr corto 15 cms.8.Was the device flushed before the procedure, as per ifu? yes.9.What was the target location for the complaint device? femoral superficial.10.Was the patient's anatomy tortuous or calcified? yes.11.Was resistance encountered when advancing the wire guide or delivery system to the target location? yes, thrombosed a big segment of femoral superficial.How did the physician deal with this resistance? 12.Did the stent delivery system cross the target location? yes, but he needed another stent no farmacoactivo for no stock of zilver of this measure.13.What artery was the stent placed in? femoral superficial.14.Is the patient known to be covid-19 positive? no.

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # p100022/s027.Device evaluation the zisv6-35-125-5.0-80-ptx device of lot number c1746554 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation ¿ n/a.Document review prior to distribution zisv6-35-125-5.0-80-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 zisv6-35-125-5.0-80-ptx of lot number c1746554 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 c1746554.It should be noted that the instructions for use (ifu0117-5) states the following: ¿prior to disengaging the device safety lock ensure the distal end of the stability sheath is inside the introducer sheath.Failure to do so may result in stent damage and/or stent compression upon deployment.¿ there is evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression: deployment of zisv6-35-125-5.0-80-ptx stent to a length of 40.93mm is confirmed.The stent was deployed just after successful deployment of another zilver ptx stent in the distal sfa.The first stent was likely deployed with the stability sheath inside the access sheath.The concertinaed stent was likely deployed with the stability sheath outside the access sheath.This would have advanced the delivery system during deployment causing the stent to concertina.The advancement would have been particularly unexpected given normal deployment of the first stent.Root cause review: a definitive root cause of the stability sheath being outside the access sheath during deployment was identified from the available information.As per the imaging review the complaint stent was likely deployed with the stability sheath outside the access sheath which would have advanced the delivery system during deployment causing the stent to concertina.Summary: complaint is confirmed as the failure was verified in the image(s).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

Supplemental report is being submitted due to the completion of the investigation.

Event Description

Supplemental report is being submitted due a correction to the c code complete on 12-jan-2024.

Manufacturer Narrative

Pma/510(k) # p100022/s027.Device evaluation: the zisv6-35-125-5.0-80-ptx device of lot number c1746554 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation ¿ n/a.Document review: prior to distribution zisv6-35-125-5.0-80-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 zisv6-35-125-5.0-80-ptx of lot number c1746554 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 c1746554.It should be noted that the instructions for use (ifu0117-5) states the following: ¿prior to disengaging the device safety lock ensure the distal end of the stability sheath is inside the introducer sheath.Failure to do so may result in stent damage and/or stent compression upon deployment.¿ there is evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: impression: deployment of zisv6-35-125-5.0-80-ptx stent to a length of 40.93mm is confirmed.The stent was deployed just after successful deployment of another zilver ptx stent in the distal sfa.The first stent was likely deployed with the stability sheath inside the access sheath.The concertinaed stent was likely deployed with the stability sheath outside the access sheath.This would have advanced the delivery system during deployment causing the stent to concertina.The advancement would have been particularly unexpected given normal deployment of the first stent.Root cause review: a definitive root cause of the stability sheath being outside the access sheath during deployment was identified from the available information.As per the imaging review the complaint stent was likely deployed with the stability sheath outside the access sheath which would have advanced the delivery system during deployment causing the stent to concertina.Summary: complaint is confirmed as the failure was verified in the image(s).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
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 10712600
• MDR Text Key: 244371810
• Report Number: 3001845648-2020-00802
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352756
• UDI-Public: (01)10827002352756(17)220630(10)C1746554
• Combination Product (y/n): Y
• Reporter Country Code: ES
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: ZISV6-35-125-5.0-80-PTX
• Device Lot Number: C1746554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2020
• Event Location: Hospital
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention