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

Catalog Number ZISV6-35-125-7-80-PTX

Device Problem Difficult to Remove (1528)

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

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported by the dm on behalf of the customer via phone call: while performing an angiogram treating an sfa when loading the device into position, deployed the stent successfully with no issue.However, when attempting to remove the delivery device of the stent it became completely stuck on the wire it was over.The wire and the delivery device were removed at the same time to continue the rest of the procedure.Procedure was completed successfully.Patient outcome: the following has been answered: (b)(6) 2020.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? no.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.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? no.Patient/event info - notes: the following has been answered: (b)(6) 2020.Where was the access site? right above the femoral head on the right groin 1.3 what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.No.What was the target location for the stent? distal left sfa was the target location severely calcified or tortuous? no, it was a focal lesion and was not super calcified.Was the device flushed prior to use? yes.Were there any difficulties deploying the stent? no.Was the stent fully deployed before removing the delivery system from the patient? yes.What other devices were used in the procedure? 5f 65cm ansel shealth, a variety of wire including an benson and amplatz wire,.035 and.018 cook balloons, delivered another ptx earlier in the case as well as a bare metal zilver.Terumo glide cath and a boston scientific platinum plus wire.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? no.Was the stent eventually deployed? yes.Was pre-dilatation conducted before stent deployment? yes.Was the handle pulled toward the hub while the delivery system remained stationary during deployment? n/a.Was the wire guide hydrophilic or non-hydrophilic? non-hydrophyllic.How long was the procedure from advancing delivery system to the moment when the user attempted to remove the device? a few minutes.Was the wire guide new or was the wire guide used previously before advancing the zilver delivery system? the wire guide was already in the patient if used, was the wire guide wiped between uses? no the outside portion was not wiped between uses.Per the dm- the wire that the ptx was delivered with is included in the return as it is stuck in the ptx.

Event Description

Supplemental report being submitted due to the completion of the investigation.Reported by the dm on behalf of the customer via phone call- while performing an angiogram treating an sfa when loading the device into position, deployed the stent successfully with no issue.However, when attempting to remove the delivery device of the stent it became completely stuck on the wire it was over.The wire and the delivery device were removed at the same time to continue the rest of the procedure.Procedure was completed successfully.Device evaluated on (b)(6) 2020: wire guide stuck in handle/delivery sheath and handle dismantled on return.Patient outcome: the following has been answered- (b)(6) 2020.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? no.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.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? no.Patient/event info - notes: the following has been answered- (b)(6) 2020.Where was the access site? right above the femoral head on the right groin 1.3 what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.No.What was the target location for the stent? distal left sfa.Was the target location severely calcified or tortuous? no, it was a focal lesion and was not super calcified.Was the device flushed prior to use? yes.Were there any difficulties deploying the stent? no.Was the stent fully deployed before removing the delivery system from the patient? yes.What other devices were used in the procedure? 5f 65cm ansel shealth, a variety of wire including an benson and amplatz wire,.035 and.018 cook balloons, delivered another ptx earlier in the case as well as a bare metal zilver.Terumo glide cath and a boston scientific platinum plus wire.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? no.Was the stent eventually deployed? yes.Was pre-dilatation conducted before stent deployment? yes.Was the handle pulled toward the hub while the delivery system remained stationary during deployment? n/a.Was the wire guide hydrophilic or non-hydrophilic? non-hydrophyllic.How long was the procedure from advancing delivery system to the moment when the user attempted to remove the device? a few minutes.Was the wire guide new or was the wire guide used previously before advancing the zilver delivery system? the wire guide was already in the patient.If used, was the wire guide wiped between uses? no the outside portion was not wiped between uses.Per the dm- the wire that the ptx was delivered with is included in the return as it is stuck in the ptx.

Manufacturer Narrative

Device evaluation the zisv6-35-125-7-80-ptx device of lot number c1704829 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.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the (b)(6) 2020.Refer to attachments.On evaluation of the device the wire guide from the procedure was returned in the delivery system and could not be removed during the lab evaluation.As a result of the wire guide being stuck in the delivery system the device could not be flushed and a wire could not be advanced through it during the device evaluation.The wire guide measured 0.035¿.The handle of the delivery system was disassembled on return of the device.Document review: prior to distribution zisv6-35-125-7-80-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 zisv6-35-125-7-80-ptx of lot number c1704829 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 c1704829.The instructions for use (ifu0118-6) states the following: ¿a 0.035 inch (0.89mm) 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.¿ ¿following stent deployment, if resistance is met during the withdrawal of the delivery system, carefully remove the delivery system and wire guide as a unit.If resistance is still encountered during removal of the delivery system and wire guide as a unit, remove the wire guide, delivery system and introducer sheath together as a unit.¿ there is no evidence to suggest the user did not follow the ifu.Root cause review.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to congealed blood in the delivery system.It is possible that congealed blood bound the wire guide and the outer sheath preventing removal of the device over the wire guide resulting in both the wire guide and the delivery system being removed together after stent deployment.From the information provided by the customer it is known that the user disassembled the handle during the procedure when the device because stuck on the wire after deploying the stent in an attempt to remove the device from the wire.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.

Manufacturer Narrative

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

Event Description

Device evaluated on 09-oct-2020: wire guide stuck in handle/delivery sheath and handle dismantled on return.Previously reported: while performing an angiogram treating an sfa when loading the device into position, deployed the stent successfully with no issue.However, when attempting to remove the delivery device of the stent it became completely stuck on the wire it was over.The wire and the delivery device were removed at the same time to continue the rest of the procedure.Procedure was completed successfully.Patient outcome: the following has been answered- (b)(6) 2020.Did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.Did the patient require any additional procedures due to this occurrence? no 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.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? no patient/event info - notes: the following has been answered- (b)(6) 2020 where was the access site? right above the femoral head on the right groin 1.3 what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.No what was the target location for the stent? distal left sfa was the target location severely calcified or tortuous? no, it was a focal lesion and was not super calcified was the device flushed prior to use? yes were there any difficulties deploying the stent? no was the stent fully deployed before removing the delivery system from the patient? yes what other devices were used in the procedure? 5f 65cm ansel shealth, a variety of wire including an benson and amplatz wire,.035 and.018 cook balloons, delivered another ptx earlier in the case as well as a bare metal zilver.Terumo glide cath and a boston scientific platinum plus wire.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? no was the stent eventually deployed? yes was pre-dilatation conducted before stent deployment? yes was the handle pulled toward the hub while the delivery system remained stationary during deployment? n/a was the wire guide hydrophilic or non-hydrophilic? non-hydrophyllic how long was the procedure from advancing delivery system to the moment when the user attempted to remove the device? a few minutes was the wire guide new or was the wire guide used previously before advancing the zilver delivery system? the wire guide was already in the patient if used, was the wire guide wiped between uses? no the outside portion was not wiped between uses.**per the dm- the wire that the ptx was delivered with is included in the return as it is stuck in the ptx.

• 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: 10541246
• MDR Text Key: 207229437
• Report Number: 3001845648-2020-00610
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Catalogue Number: ZISV6-35-125-7-80-PTX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2020
• Event Location: Hospital
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 114