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

Model Number	G38490
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # p100022/s014.The investigation is in progress and a follow up mdr will be submitted.
Event or Problem Description
As initially reported to customer relations via phone: a 60 year old male patient underwent a stenting of the sfa procedure in which the zilver ptx 35 drug-eluting stent.G38490, was used.It was noted the patient had a very tight bifurcation and the device was hard to do up and over and then into position.The physician started deploying and the device broke after 30mm of deployment.The district manager and physician broke open the handle to deploy and the handle broke.Eventually was able to deploy the stent but the stent was elongated about 200 mm and deformed.The stent was left in the patient and the physician deployed a lifestent 6x150 inside the zilver to open up the zilver.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? no.If yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.Prefix ziv6-ptx/zisv6-ptx.Are images (e.G.Angiography, us etc.) of the device and/or procedure available? yes.Was the device flushed before the procedure, as per ifu? yes.Were there any issues with flushing of the device? no.Details of the access sheath used (name, fr size,length)?6x55 high flex ansel due to tight bifurcation.Details of the wire guide used (name, diameter, hyrdophyllic)? amplatz.035.What approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other contralateral- right access.Please specify for other: if contralateral, was the bifurcation angle steep? very tight bifurcation.What was the target location for the stent? sfa central distal.What artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other sfa left.Please specify for other: was the wire guide removed from the patient prior to advancing the delivery system? no.If removed, was the wire guide wiped prior to advancement of the delivery system? yes but wasn't removed.Did the stent delivery system cross the target location? yes.Was pre-dilation performed ahead of placement of the stent? yes.Was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other, tight torque bifurcation.If other, please specify: was resistance encountered when advancing the wire guide? no.Was resistance encountered when advancing the delivery system to the target location? yes.Was resistance encountered when deploying the stent? no.How did the physician deal with any resistance encountered? n/a.Was the stent fully deployed in the patient before removing the delivery system? no-- 30mm of 120mm stent.After deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other.Elongated & deformed.If other, please specify: was post-dilation performed after the placement of the stent? yes, before 2dn stent placement.Did any portion of the device break off? no.If yes, please state what part: when did the device break? n/a, prep, advancement, deployment, withdrawal, after removal.Deployment.Thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? no.Thumbwheel only ¿ was the retraction sheet being held during deployment.No.Did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? yes, after cable broke.If yes, was the stent partially deployed? yes.If yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? deployed in patient & left in patient.If removed, did any part of the stent fracture during removal of the delivery system? n/a did not remove.Was the delivery system kinked or twisted during advancement or deployment? no.Please advise if and when any damage was observed on the; wireguide -- no.Prior to use, during use, post procedure.Delivery system-- handle was cut to try to deploy stent.Prior to use, during use, post procedure.If yes, please specify (e.G.Kinked or twisted): n/a.What intervention (if any) was required? placed a competitors stent inside the zilver to open.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure as device difficulty.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no.Please specify if yes.
Additional Manufacturer Narrative
Pma/510(k) #p100022/s014; device evaluation: 1 unit of zisv6-35-125-7-120-ptx lot#c1766637 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.  lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 24 jan 2022.On evaluation of the device the handle was observed to be separated.Kinks observed on the flexor 12.5cm, 14cm and 48.5cm from the proximal end of the flla adapter.Retraction wire separated from the stent retraction sheath.No functional checks could be carried out on the device due to device being returned in multiple parts.  documents review including ifu review: prior to distribution zisv6-35-125-7-120-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 zisv6-35-125-7-120-ptx of lot number c1766637 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 c1766637.It should be noted that the instructions for use (ifu0118) states the following: ¿if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device¿.There is sufficient evidence to suggest the user did not follow the ifu.As per complaint description "it was noted the patient had a very tight bifurcation and the device was hard to do up and over and then into position." customer confirmed resistance encountered through additional questions "was resistance encountered when advancing the delivery system to the target location? yes"   image review: n/a.  root cause review: a definitive root cause of user error: physician/assistant does not read/follow instructions was identified in the laboratory.As per the instructions for use for the device ¿if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device¿.All of the failure modes that followed the user error of not following this instruction were deemed to be cascading from the initial forced advancement of the device   summary:  complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The zilver ptx stent was deployed deformed which required the physician to deploy a lifestent 6x150 inside the zilver ptx stent to ensure patency of the zilver ptx stent.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 13342692
• Report Number: 3001845648-2022-00039
• Device Sequence Number: 4064444
• Product Code: NIU
• UDI-Device Identifier: 10827002384900
• UDI-Public: (01)10827002384900(17)220907(10)C1766637
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2022
• Device Model Number: G38490
• Device Catalogue Number: ZISV6-35-125-7-120-PTX
• Device Lot Number: C1766637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2021
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female