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

Model Number G38532

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

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

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Per customer - (b)(6) 2020 - dr.(b)(6) attempted to put a zilver stent in the transverse sinus of our patient today.The stent unfortunately would not deploy and he wanted me to reach out to you, possibly send the stent back and receive a credit.The stent we used was a 8mmx120mm zilver ptx, ref# (b)(4) and lot #c1754693.Per customer - (b)(6) 2020 - how was the procedure completed? -we had to use a stent from a different company.Patient outcome: 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.Patient/event info - notes: examples of rpn prefixes (but not limited to): zib5, zib6 ,ziv5.Zisv6, zvt7, ziv6.General questions for complaint occurring during use, request the following: where was the access site? -femoral artery.What was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.-the patient had tortuous anatomy.What was the target location for the stent? -transverse sinus.¿ was the target location severely calcified or tortuous? -the target location was not calcified or tortuous but the approach was tortuous around the jugular vein.Was the device flushed prior to use? yes.Were there any difficulties deploying the stent? -stent would not deploy.Was the stent fully deployed before removing the delivery system from the patient? -stent would not deploy.What other devices were used in the procedure? -the zilver stent would not deploy so we switch over to a wallstent which we were able to deploy after navigation around the tortuous segment.¿ please provide manufacturer, model, brand, and size if possible.Were any additional procedures necessary as a result of this event? -no.Can any photos, images, or reports of the procedure or device be provided? -i have the device with the undeployed stent available.Please review following ¿failure¿ modes with contact to determine if additional questions apply.If the event involving deployment difficulties, request the following: was the stent eventually deployed? no.Was pre-dilatation conducted before stent deployment? no.

Manufacturer Narrative

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

Event Description

Supplemental follow-up report is being submitted due to the receipt of additional information: the customer has provided answers to the following questions on (b)(6) 2020: 1.Are images of the device or procedure available? we sent the device back to cook.Images of the procedure are available.2.Was the approach ipsilateral or contralateral? contralateral? we accessed the right femoral vein, went up the superior vena cava then placed a neuron max at the left jugular bulb.3.If contralateral, was the bifurcation angle tight? 4.Details of the wire guide used (name, diameter, hydrophyllic)? terumo stiffened glide wire 0.035x 150cm hydrophylic, boston scientific amplatz super stiff 0.035x26cm., stryker synchro 2 soft 0.014x200cm hydrophylic, and boston scientific fathom-14 x300cm 4.Details of the access sheath used (name, fr size, length)? penumbra 6fr neuron max 088 sheath x90cm 6.Was resistance encountered when advancing the wire guide to the target location? yes 6a.How did the physician deal with this resistance? carefully with gentle force 6b.Was resistance encountered when advancing the delivery system to the target location? yes.6c.How did the physician deal with this resistance? carefully with gentle force 7.Did the stent delivery system cross the target location? the stent delivery was at the target location but due to the tortuous approach the stent would not deploy the customer has reported the following info on (b)(6) 2020: 1.Can the imaging be forwarded to us for review? i will send images of the anatomy but unfortunately there are no images of the zilver because it was never deployed.We only save images of a stent typically after its deployed.2.What is a neuron max? neuron max 088 is a 6 f (2.03 mm) long sheath.0.088 (2.24 mm) lumen that allows for a wide range of device compatibility.2a.Was this placed prior to the user advancing the zilver ptx device? yes 3.Could you confirm which size wire guide was used with the zilver ptx device? all of these were attempted.Terumo stiffened glide wire 0.035x 150cm hydrophylic, boston scientific amplatz super stiff 0.035x26cm., stryker synchro 2 soft 0.014x200cm hydrophylic, and boston scientific fathom-14 x300cm.Initial report details: per customer - (b)(6) 2020 - dr.(b)(6)attempted to put a zilver stent in the transverse sinus of our patient today.The stent unfortunately would not deploy and he wanted me to reach out to you, possibly send the stent back and receive a credit.The stent we used was a 8mmx120mm zilver ptx, ref#(b)(4) and lot #c1754693.Per customer - (b)(6) 2020 - how was the procedure completed? -we had to use a stent from a different company.Patient outcome: 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.Patient/event info - notes: 1.1 general questions for complaint occurring during use, request the following: 1.2 where was the access site? -femoral artery 1.3 what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.-the patient had tortuous anatomy.1.4 what was the target location for the stent? -transverse sinus.¿ was the target location severely calcified or tortuous? -the target location was not calcified or tortuous but the approach was tortuous around the jugular vein.1.5 was the device flushed prior to use? yes.1.6 were there any difficulties deploying the stent? -stent would not deploy 1.7 was the stent fully deployed before removing the delivery system from the patient? -stent would not deploy.1.8 what other devices were used in the procedure? -the zilver stent would not deploy so we switch over to a wallstent which we were able to deploy after navigation around the tortuous segment.¿ please provide manufacturer, model, brand, and size if possible.1.9 were any additional procedures necessary as a result of this event? -no.1.10 can any photos, images, or reports of the procedure or device be provided? -i have the device with the undeployed stent available.2.0 please review following ¿failure¿ modes with contact to determine if additional questions apply.2.1 if the event involves thombosis, restenosis, and/or occlusion, request the following: -n/a.2.2 if the event involved claudication / pain, request the following: -n/a.2.3 if the event involves stent shortening, request the following: -n/a.2.4 if the event involves sheath separation, request the following: -n/a.2.5 if the event involving deployment difficulties, request the following: 2.5.1 was the stent eventually deployed? no.2.5.2 was pre-dilatation conducted before stent deployment? no.2.5.3 was the handle pulled toward the hub while the delivery system remained stationary during deployment? 2.6 if the event that involve device stuck on wire guide, difficult to advance / remove delivery system and/or wire guide, request the following: 2.6.1 was the wire guide hydrophilic or non-hydrophilic? 2.6.2 how long was the procedure 0from advancing delivery system to the moment when the user attempted to remove the device? 2.6.3 was the wire guide new or was the wire guide used previously before advancing the zilver delivery system? 2.6.3.1 if used, was the wire guide wiped between uses?.

Manufacturer Narrative

Annex g: g07001 - part/component/sub-assembly term not applicable.Device evaluation: the zisv6-35-125-8-120-ptx device of lot number c1754693 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 06 november 2020.On evaluation of the device damage was observed on the clear section of the outer sheath approx.13.5 cm to 33.5 cm from the distal white tip.The clear section of the outer sheath and the coiled section on the sheath were unravelled in places and not returned with the device from approx.17.5 cm to 33.5 cm on the outer sheath.The handle was dismantled during the lab evaluation and the retraction wire was observed to be separated from the stent retraction sheath (srs).The device flushed as expected but a 0.035¿ wire guide could not pass beyond the damage on the outer sheath.Document review: prior to distribution zisv6-35-125-8-120-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 zisv6-35-125-8-120-ptx of lot number c1754693 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 c1754693.It should be noted that the instructions for use (ifu0118-6) states the following: ¿the zilver ptx drug-eluting peripheral stent is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7mm and total lesion lengths up to 300 mm per patient.¿ ¿a 0.035 inch (0.89 mm) diameter wire guide should be used during tracking, deployment, and removal in order 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.Root cause review: a definitive root cause of off-label use was identified from the available information.From the information provided it is known that the target location for the device was the transverse sinus.It is also known that the user attempted to use the zilver ptx device with multiple wire guides one of which was a 0.014¿ wire guide.It is possible that the use of the device in an unintended location along with the use of a non-recommended wire guide resulted in increased resistance during advancement and increased deployment forces during attempted deployment resulting in the damage observed on the outer sheath and the retraction wire becoming separated from the srs during attempted deployment, both of which would have prevented the user from deploying the stent.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.

Event Description

Supplemental report being submitted due to the investigation being completed on 17-feb-2021.

• 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: 10813834
• MDR Text Key: 253256908
• Report Number: 3001845648-2020-00838
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002385327
• UDI-Public: (01)10827002385327(17)220406(10)C1754693
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2022
• Device Model Number: G38532
• Device Catalogue Number: ZISV6-35-125-8-120-PTX
• Device Lot Number: C1754693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/12/2020
• Event Location: Hospital
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR