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

Catalog Number ZISV6-35-80-7.0-40-PTX

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # = this specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore mdr reporting criteria applicable to this event.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

(b)(6) opened the packaging in preparation to use this ptx stent and noticed that the stent was protruding out of the delivery sheath.The product was not in contact with the patient it was returned to original packaging for return to cook.

Event Description

(b)(6) opened the packaging in preparation to use this ptx stent and noticed that the stent was protruding out of the delivery sheath.The product was not in contact with the patient it was returned to original packaging for return to cook.

Manufacturer Narrative

Pma/510(k) # = this specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore mdr reporting criteria applicable to this event.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).Device evaluation the zisv6-35-80-7.0-40-ptx device of lot number c1476637 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.It should be noted that a number of requests were made to determine at what point the safety trigger was depressed.Requests were also made to determine whether the correct device was returned as the returned device did not match the complaint description.At the time of the investigation this information had not been received.The investigation will be updated in the future if this information becomes available to cirl.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 15 november 2018.The stent was protruding from the stent retraction sheath (srs) and the red safety trigger was depressed.The device related to this occurrence underwent re-evaluation in the laboratory on the 31st january 2019.The returned device lab examination findings and observations can be referred through attached photos.The red safety lock was depressed and the stent was partially deployed.The device was flushed and wired without issue and the stent was deployed without issue but the gold rivets were damaged.Engineering provided the following information after this device was re-evaluated in the laboratory: ¿ ¿the device was definitely tracked through a patient¿s body due to the presence of blood at the distal end and inside the srs ¿ deployment was initiated because the red button is depressed and the stent has started to deploy.But the stent is severely distorted and the distal end of the srs tubing is damaged/torn.¿ deployment was stopped but not because the device didn¿t continue to work.We were able to flush, wire it and complete deployment in the lab.No issue with the retraction wire.¿ document review prior to distribution zisv6-35-80-7.0-40-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 zisv6-35-80-7.0-40-ptx of lot number c1476637 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 c1476637.There is no evidence to suggest the user did not follow the instructions for use.It should be noted that the instructions for use states the following: ¿precautions ¿ do not try to remove the stent from the introducer system before use.¿ ensure that the red safety lock is not inadvertently depressed before stent deployment is desired.Alignment and deployment of the stent 4.Rotating the thumbwheel will withdraw the retraction sheath from over the stent.Note: stent deployment will begin once the distal radiopaque stent markers have advanced beyond the sheath marker band (refer to figure 1.For sheath and stent marker identification).Once the stent has apposed the vessel wall repositioning of the stent is not recommended.Recapture or re-sheathing of the zilver ptx drug eluting peripheral stent is not possible because the stent retraction sheath cannot be re-advanced.¿ 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 the physician depressing the red safety trigger prior to reaching the desired deployment site and the device as a result, getting caught in a previously placed stent during advancement and/or attempted deployment damaging the end cell and rivets and damaging the distal end of the srs as a result.A possible root cause could also be attributed to the physician attempting to reposition the stent after deployment had commenced.It is possible that this caused and/or contributed to the end cell and rivets to push back and be distorted out of shape resulting in damage on the stent retraction sheath (srs).It should be noted that a failure mode of ¿user error¿ has been assigned to this file as limited information was available during the investigation.The failure mode will be re-assessed and the investigation and the risk assessment will be updated if any additional information is received by cirl in the future.Summary complaint is confirmed as the failure was verified in the laboratory.The stent was protruding from the stent retraction sheath (srs).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

Dr (b)(6) opened the packaging in preparation to use this ptx stent and noticed that the stent was protruding out of the delivery sheath.The product was not in contact with the patient it was returned to original packaging for return to cook.

Manufacturer Narrative

Pma/510(k) # = this specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore mdr reporting criteria applicable to this event.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)(6).(b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Dr shah opened the packaging in preparation to use this ptx stent and noticed that the stent was protruding out of the delivery sheath.The product was not in contact with the patient it was returned to original packaging for return to cook.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿premature stent deployment with safety lock in place¿ and '"stent deformation due to stent catching on previously placed stent." no adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Pma/510(k) #: this specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore mdr reporting criteria applicable to this event.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: (b)(4).Device evaluation: the zisv6-35-80-7.0-40-ptx device of lot number c1476637 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.It should be noted that a number of requests were made to determine at what point the safety trigger was depressed.Requests were also made to determine whether the correct device was returned as the returned device did not match the complaint description.At the time of the investigation this information had not been received.The investigation will be updated in the future if this information becomes available to cirl.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 15 november 2018.The stent was protruding from the stent retraction sheath (srs) and the red safety trigger was depressed.The device related to this occurrence underwent re-evaluation in the laboratory on the 31st january 2019.The returned device lab examination findings and observations can be referred through attached photos.The red safety lock was depressed and the stent was partially deployed.The device was flushed and wired without issue and the stent was deployed without issue but the gold rivets were damaged.Engineering provided the following information after this device was re-evaluated in the laboratory: ¿the device was definitely tracked through a patient¿s body due to the presence of blood at the distal end and inside the srs.Deployment was initiated because the red button is depressed and the stent has started to deploy.But the stent is severely distorted and the distal end of the srs tubing is damaged/torn.Deployment was stopped but not because the device didn¿t continue to work.We were able to flush, wire it and complete deployment in the lab.No issue with the retraction wire.¿ document review: prior to distribution zisv6-35-80-7.0-40-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 zisv6-35-80-7.0-40-ptx of lot number c1476637 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 c1476637.There is no evidence to suggest the user did not follow the instructions for use.It should be noted that the instructions for use states the following: ¿precautions: do not try to remove the stent from the introducer system before use.Ensure that the red safety lock is not inadvertently depressed before stent deployment is desired.Alignment and deployment of the stent: 4.Rotating the thumbwheel will withdraw the retraction sheath from over the stent.Note: stent deployment will begin once the distal radiopaque stent markers have advanced beyond the sheath marker band (refer to figure 1.For sheath and stent marker identification).Once the stent has apposed the vessel wall repositioning of the stent is not recommended.Recapture or re-sheathing of the zilver ptx drug eluting peripheral stent is not possible because the stent retraction sheath cannot be re-advanced.¿ 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 the physician depressing the red safety trigger prior to reaching the desired deployment site and the device as a result, getting caught in a previously placed stent during advancement and/or attempted deployment damaging the end cell and rivets and damaging the distal end of the srs as a result.A possible root cause could also be attributed to the physician attempting to reposition the stent after deployment had commenced.It is possible that this caused and/or contributed to the end cell and rivets to push back and be distorted out of shape resulting in damage on the stent retraction sheath (srs).It should be noted that a failure mode of ¿user error¿ has been assigned to this file as limited information was available during the investigation.The failure mode will be re-assessed and the investigation and the risk assessment will be updated if any additional information is received by cirl in the future.Summary: complaint is confirmed as the failure was verified in the laboratory.The stent was protruding from the stent retraction sheath (srs).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

Pma/510(k) # = this specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore mdr reporting criteria applicable to this event.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)(6).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Dr shah opened the packaging in preparation to use this ptx stent and noticed that the stent was protruding out of the delivery sheath.The product was not in contact with the patient it was returned to original packaging for return to cook.

• 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
• MDR Report Key: 8089055
• MDR Text Key: 129101570
• Report Number: 3001845648-2018-00535
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002353128
• UDI-Public: (01)10827002353128(17)200206(10)C1476637
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2020
• Device Catalogue Number: ZISV6-35-80-7.0-40-PTX
• Device Lot Number: C1476637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2018
• Event Location: Hospital
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1