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

Catalog Number ZISV6-35-125-6-140-PTX

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

The exact rpn is unknown, however from the complaint description we know the device is a zisv6-xxx-ptx, 510(k) number: p100022/s014.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This complaint is being reported under the fda mdr malfunction precedence "thumbwheel malfunctions during deployment" and "deployment difficulty resulting in partial stent deployment" as reported to customer relations: for an sfa leg procedure the zilver ptx 35 drug eluting stent was used.The physician had already placed 2 zilver ptx stents in the patient during this procedure.The 3rd stent upon deployment the thumb wheel would turn but was not retracting the sheath to deliver the stent.The physician had the tech call the district manager whom directed the physician to break open the thumb wheel and remove the spring.The to deploy the stent via the pin and pull method which the physician was familiar with.As the call was ended at this point and the district manager had not received any further calls during the procedure it appeared the procedure went as planned however the district managers has a meeting with this physician later in the week of (b)(6) 2018.

Manufacturer Narrative

The exact rpn is unknown, however from the complaint description we know the device is a zisv6-xxx-ptx, 510(k) number: p100022/s014.(b)(4).Exemption number: e2016031.(b)(4).Device evaluation: the unknown ptx device of unknown lot number has not been returned for evaluation.With the information provided, a document based investigation was conducted.From the information provided the physician had attempted to deploy the stent in the patient.Approximately one third of the stent deployed before the thumbwheel malfunctioned and the sheath would not retract any further.The physician removed the device and partially deployed stent from the patient, re-gained access and completed the procedure using another device.It is unknown whether or not the patient¿s anatomy was calcified or tortuous.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on the customer¿s testimony.A possible root cause for this complaint could include difficult patient anatomy.Difficult patient anatomy could have caused or contributed to resistance during deployment.It is possible that this resulted in higher deployment forces causing the retract wire to separate from the stent retraction sheath.However, as the device has not been returned for evaluation and as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use.It may be noted that a capa ((b)(4)) has been initiated to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.Document review as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per finished product q.C.Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on the customer¿s testimony.The risk was determined to be low (category iii).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

This complaint is being reported under the fda mdr malfunction precedence "thumbwheel malfunctions during deployment" and "deployment difficulty resulting in partial stent deployment".As reported to customer relations: for an sfa leg procedure the zilver ptx 35 drug eluting stent was used.The physician had already placed 2 zilver ptx stents in the patient during this procedure.The 3rd stent upon deployment the thumb wheel would turn but was not retracting the sheath to deliver the stent.The physician had the tech call the district manager whom directed the physician to break open the thumb wheel and remove the spring.The to deploy the stent via the pin and pull method which the physician was familiar with.As the call was ended at this point and the district manager had not received any further calls during the procedure it appeared the procedure went as planned however the district managers has a meeting with this physician later in the week of (b)(6), 2018.

Event Description

A follow up report is being submitted based on updated information received from an fda user report.This complaint is being reported under the fda mdr malfunction precedence "thumbwheel malfunctions during deployment" and "deployment difficulty resulting in partial stent deployment" as reported to customer relations: for an sfa leg procedure the zilver ptx 35 drug eluting stent was used.The physician had already placed 2 zilver ptx stents in the patient during this procedure.The 3rd stent upon deployment the thumb wheel would turn but was not retracting the sheath to deliver the stent.The physician had the tech call the district manager whom directed the physician to break open the thumb wheel and remove the spring.The to deploy the stent via the pin and pull method which the physician was familiar with.As the call was ended at this point and the district manager had not received any further calls during the procedure it appeared the procedure went as planned however the district managers has a meeting with this physician later in the week of (b)(6) 2018.

Manufacturer Narrative

The exact rpn is unknown, however from the complaint description we know the device is a zisv6-xxx-ptx, 510(k) number: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4) (importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4), importer site establishment registration number: (b)(4).This follow up report is submitted as new information has been received from an fda user report.Lot # c1470184 and rpn confirmed as zisv6-35-125-6-140-ptx.Device evaluation: the zisv6-35-125-6-140-ptx device of lot number c1470184 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The investigation will be updated once the device has been returned and evaluated.Document review: prior to distribution zisv6-35-125-6-140-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 zisv6-35-125-6-140-ptx of lot number c1470184 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 c1470184.There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a possible root cause for this complaint could include difficult patient anatomy.Difficult patient anatomy could have caused or contributed to resistance during deployment.It is possible that this resulted in higher deployment forces causing the retract wire to separate from the stent retraction sheath.Summary: the complaint is confirmed based on customer testimony.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

The exact rpn is unknown, however from the complaint description we know the device is a zisv6-xxx-ptx, 510(k) number: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4) importer site establishment registration number: (b)(4).This follow up report is submitted as new information has been received from an fda user report.Lot # c1470184 and rpn confirmed as zisv6-35-125-6-140-ptx.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

A follow up report is being submitted based on updated information received from an fda user report.This complaint is being reported under the fda mdr malfunction precedence "thumbwheel malfunctions during deployment" and "deployment difficulty resulting in partial stent deployment" as reported to customer relations: for an sfa leg procedure the zilver ptx 35 drug eluting stent was used.The physician had already placed 2 zilver ptx stents in the patient during this procedure.The 3rd stent upon deployment the thumb wheel would turn but was not retracting the sheath to deliver the stent.The physician had the tech call the district manager whom directed the physician to break open the thumb wheel and remove the spring.The to deploy the stent via the pin and pull method which the physician was familiar with.As the call was ended at this point and the district manager had not received any further calls during the procedure it appeared the procedure went as planned however the district managers has a meeting with this physician later in the week of (b)(6) 2018.

Event Description

A follow up report is being submitted based on device return.This complaint is being reported under the fda mdr malfunction precedence "thumbwheel malfunctions during deployment" and "deployment difficulty resulting in partial stent deployment." as reported to customer relations: for an sfa leg procedure the zilver ptx 35 drug eluting stent was used.The physician had already placed 2 zilver ptx stents in the patient during this procedure.The 3rd stent upon deployment the thumb wheel would turn but was not retracting the sheath to deliver the stent.The physician had the tech call the district manager whom directed the physician to break open the thumb wheel and remove the spring.The to deploy the stent via the pin and pull method which the physician was familiar with.As the call was ended at this point and the district manager had not received any further calls during the procedure it appeared the procedure went as planned however the district managers has a meeting with this physician later in the week of (b)(6) 2018.

Manufacturer Narrative

The exact rpn is unknown, however from the complaint description we know the device is a zisv6-xxx-ptx, 510(k) number: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation: the zisv6-35-125-6-140-ptx device of lot number c1470184 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 20 june 2019.On evaluation of the device, the handle was disassembled, the entire stent was inside the delivery system, the stent retraction sheath (srs) was heavily damaged and the retraction wire was separated from the srs.The access sheath was found to be stuck on the srs.The access sheath was pulled proximally in the lab in order to see the damage on the srs more clearly.It was then identified that the clear section of the srs was torn.Document review: prior to distribution zisv6-35-125-6-140-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 zisv6-35-125-6-140-ptx of lot number c1470184 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 c1470184.There is no evidence to suggest that the customer did not follow the instructions for use.Image review ¿ n/a.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 for this complaint could include difficult patient anatomy.Difficult patient anatomy could have caused and/or contributed to resistance during deployment.It is possible that this resulted in higher deployment forces causing the retract wire to separate from the stent retraction sheath.From the information provided it is known that the handle was disassembled by the physician during the procedure.It is possible that a difficult patient anatomy could have resulted in the damage to the srs as observed in the laboratory.It is possible that congealed blood bound the access sheath to the srs.It is also possible that this caused and/or contributed to resistance during advancement and combined with potentially difficult anatomy, it is possible that this resistance and the access sheath bound to the srs caused and/or contributed to the clear section of the srs tearing.Summary: the 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 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: 7875970
• MDR Text Key: 121447287
• Report Number: 3001845648-2018-00429
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2020
• Device Catalogue Number: ZISV6-35-125-6-140-PTX
• Device Lot Number: C1470184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR