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

Model Number G38463

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As initially reported to customer relations via phone discussion & submitted email from district manager per the customer: patient was in interventional radiology for ir thrombolysis therapy and angiogram.During the procedure a zilver ptx 6mmx 40mm stent was used and it prematurely deployed.While this stent was bring retracted, using the filter and the filter wire, part of the stent sheared off near the left common femoral artery access site.Ct was ordered to determine exact location of sheared off site.Per ct: no definite intravascular foreign body is visualized.Questionable hyperdense fractured stent material surrounding the sheath.Sent described about has been saved.Patient was subsequently transferred to summit (account c12616-36) in the event further intervention was required.Additional information provided 07nov2019: (b)(6) 2019 patient was in the hospital previously receiving thrombolysis for severe clots.Patient had previous stents that were totally occluded.They had a 6x45 ansel sheath and a.018 spider filter wire that was placed below the knee.Physician did a pre-angioplasty at the target location.They then advanced a cook bentson.035 wire down and then tracked the zilver ptx delivery catheter over the bentson wire.This system was running along side the.018 spider wire.Physician did feel resistance while advancing the ptx.Once the zilver ptx was outside of the ansel sheath, the physician noticed that the stent was partially deployed.He stopped advancing the system at this point.Physician waited until another physician arrived to help with the situation.The physicians were concerned about the spider wire that was placed below the knee.They were not able to close the filter and were concerned about pulling the spider wire out because they didn¿t want it getting caught on the stents that were placed last year.They decided to slowly pull the spider wire up to where the stent was deployed in hopes that the filter wire would hold the stent in place as they pulled the entire system out of the body.They pulled everything out except the bentson wire.That is when they noticed that part of the stent broke off and was inside the patient.At this point they had the wire down and put in another sheath.They did an angio and could not see any portion of the stent inside the body.They determined that the portion of the stent was probably in the soft tissue at the access site.I asked if the red safety was pressed.They said it was not pressed.I asked if the thumbwheel was turned at any point while advancing and they said it was not.Patient was sent to ct after the procedure to get a ct scan to determine if the stent was in the body.Here is the ct scan finding: ct scan finding: no definitive vascular foreign body is visualized.Questionable hyperdensed fractured stent material surrounding the sheath.The next day the patient was brought back to the angio suite.This was not due to this procedure.Patient had clots and they needed to do an intervention.The next day they did end up putting a 6x40 zilver ptx in the location that they previously wanted to place it in.They did a pre angioplasty, then used a dcb, and they placed the ptx.This procedure was done on (b)(6) 2019.There was no incident during this procedure.Afterwards, they patient was sent to another facility but it was not related to the incident that occurred on (b)(6) 2019.Patient was not harmed during the procedure.Patient did have a follow up appointment with her wound care physician and her open wound has started to heal and has not reported any adverse events due to this procedure.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 as the patient required intervention and a ct scan to determine if the fractured stent was left in the patient also 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 fracture'.

Event Description

As initially reported to customer relations via phone discussion & submitted email from district manager per the customer: patient was in interventional radiology for ir thrombolysis therapy and angiogram.During the procedure a zilver ptx 6mmx 40mm stent was used and it prematurely deployed.While this stent was bring retracted, using the filter and the filter wire, part of the stent sheared off near the left common femoral artery access site.Ct was ordered to determine exact location of sheared off site.Per ct: no definite intravascular foreign body is visualized.Questionable hyperdense fractured stent material surrounding the sheath.Sent described about has been saved.Patient was subsequently transferred to summit (account (b)(6) ) in the event further intervention was required.Additional information provided 07nov2019: the (b)(6) 2019 patient was in the hospital previously receiving thrombolysis for severe clots.Patient had previous stents that were totally occluded.They had a 6x45 ansel sheath and a.018 spider filter wire that was placed below the knee.Physician did a pre-angioplasty at the target location.They then advanced a cook bentson.035 wire down and then tracked the zilver ptx delivery catheter over the bentson wire.This system was running along side the.018 spider wire.Physician did feel resistance while advancing the ptx.Once the zilver ptx was outside of the ansel sheath, the physician noticed that the stent was partially deployed.He stopped advancing the system at this point.Physician waited until another physician arrived to help with the situation.The physicians were concerned about the spider wire that was placed below the knee.They were not able to close the filter and were concerned about pulling the spider wire out because they didn¿t want it getting caught on the stents that were placed last year.They decided to slowly pull the spider wire up to where the stent was deployed in hopes that the filter wire would hold the stent in place as they pulled the entire system out of the body.They pulled everything out except the bentson wire.That is when they noticed that part of the stent broke off and was inside the patient.At this point they had the wire down and put in another sheath.They did an angio and could not see any portion of the stent inside the body.They determined that the portion of the stent was probably in the soft tissue at the access site.I asked if the red safety was pressed.They said it was not pressed.I asked if the thumbwheel was turned at any point while advancing and they said it was not.Patient was sent to ct after the procedure to get a ct scan to determine if the stent was in the body.Here is the ct scan finding: ct scan finding ¿ no definitive vascular foreign body is visualized.Questionable hyperdensed fractured stent material surrounding the sheath.The next day the patient was brought back to the angio suite.This was not due to this procedure.Patient had clots and they needed to do an intervention.The next day they did end up putting a 6x40 zilver ptx in the location that they previously wanted to place it in.They did a pre angioplasty, then used a dcb, and they placed the ptx.This procedure was done on (b)(6) 2019.There was no incident during this procedure.Afterwards, they patient was sent to another facility but it was not related to the incident that occurred on (b)(6) 2019.Patient was not harmed during the procedure.Patient did have a follow up appointment with her wound care physician and her open wound has started to heal and has not reported any adverse events due to this procedure.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 as the patient required intervention and a ct scan to determine if the fractured stent was left in the patient also 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 fracture'.

Manufacturer Narrative

Pma/510(k) #: p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As initially reported to customer relations via phone discussion & submitted email from district manager per the customer: patient was in interventional radiology for ir thrombolysis therapy and angiogram.During the procedure a zilver ptx 6mmx 40mm stent was used and it prematurely deployed.While this stent was bring retracted, using the filter and the filter wire, part of the stent sheared off near the left common femoral artery access site.Ct was ordered to determine exact location of sheared off site.Per ct: no definite intravascular foreign body is visualized.Questionable hyperdense fractured stent material surrounding the sheath.Sent described about has been saved.Patient was subsequently transferred to summit in the event further intervention was required.Additional information provided 07nov2019: patient was in the hospital previously receiving thrombolysis for severe clots.Patient had previous stents that were totally occluded.They had a 6x45 ansel sheath and a.018 spider filter wire that was placed below the knee.Physician did a pre-angioplasty at the target location.They then advanced a cook bentson.035 wire down and then tracked the zilver ptx delivery catheter over the bentson wire.This system was running along side the.018 spider wire.Physician did feel resistance while advancing the ptx.Once the zilver ptx was outside of the ansel sheath, the physician noticed that the stent was partially deployed.He stopped advancing the system at this point.Physician waited until another physician arrived to help with the situation.The physicians were concerned about the spider wire that was placed below the knee.They were not able to close the filter and were concerned about pulling the spider wire out because they didn¿t want it getting caught on the stents that were placed last year.They decided to slowly pull the spider wire up to where the stent was deployed in hopes that the filter wire would hold the stent in place as they pulled the entire system out of the body.They pulled everything out except the bentson wire.That is when they noticed that part of the stent broke off and was inside the patient.At this point they had the wire down and put in another sheath.They did an angio and could not see any portion of the stent inside the body.They determined that the portion of the stent was probably in the soft tissue at the access site.I asked if the red safety was pressed.They said it was not pressed.I asked if the thumbwheel was turned at any point while advancing and they said it was not.Patient was sent to ct after the procedure to get a ct scan to determine if the stent was in the body.Here is the ct scan finding: ct scan finding ¿ no definitive vascular foreign body is visualized.Questionable hyperdensed fractured stent material surrounding the sheath.The next day the patient was brought back to the angio suite.This was not due to this procedure.Patient had clots and they needed to do an intervention.The next day they did end up putting a 6x40 zilver ptx in the location that they previously wanted to place it in.They did a pre angioplasty, then used a dcb, and they placed the ptx.This procedure was done on (b)(6) 2019.There was no incident during this procedure.Afterwards, they patient was sent to another facility but it was not related to the incident that occurred on (b)(6) 2019.Patient was not harmed during the procedure.Patient did have a follow up appointment with her wound care physician and her open wound has started to heal and has not reported any adverse events due to this procedure.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 as the patient required intervention and a ct scan to determine if the fractured stent was left in the patient also 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 fracture'.

Manufacturer Narrative

Device evaluation: the stent from the zisv6-35-125-6-40-ptx device of lot number c1613840 involved in this complaint was returned for evaluation along with a spider filter wire, without the original packaging.The packaging was open on receipt and the delivery system was not returned.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 12 december 2019.On evaluation of the device it was observed that the delivery system was not returned for evaluation.A fractured stent and a spider filter wire were returned.Approx.1.5cm of the stent was fractured and not returned.Document review: prior to distribution zisv6-35-125-6-40-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 zisv6-35-125-6-40-ptx of lot number c1613840 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 c1613840.It should be noted that the instructions for use (ifu0118-5) 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 evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer; impression: stent deployment inside the access sheath is consistent with premature stent unsheathing causing it to partially deploy.This occurred in the right cfa when the delivery sheath likely caught the end of a viabahn projecting into the cfa from the sfa.The stent then deployed inside the access sheath as the delivery system was removed.It was locked in the access sheath by the spider fx and then retracted along with the access sheath to the left cfa access.All but the stent¿s distal end was removed by spiderfx extraction.Extraction fractured the distal end on either the sheath tip or the left cfa wall.The only other alternative, inadvertent deployment with in the access sheath was not mentioned in the complaint report.Although the steep bifurcation, iliac calcification, and pre-existing stents provided challenges, only the pre-existing stents were likely to cause pre-mature deployment.If the delivery sheath edge caught on the viabahn tip or viabahn corrugation, the stent could have been exposed as the delivery cannula continued to advance.The ¿up and over¿ sheath eliminated the calcification and the stability sheath eliminated the steep bifurcation as potential causes.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 compression of the outer sheath during advancement alongside the spider filter wire resulting in resistance.From the information provided it is known that the user advanced against resistance until it was observed that the stent had partially deployed.It is possible that the resistance encountered during advancement resulted in the premature deployment of the stent.Removal of the device after partial premature deployment would have resulted in the stent fracturing.However, a ct scan performed on the patient did not identify any foreign metallic object in the patient so it is likely that the fractured stent remained on the sheath as suggested in the imaging review and complaint description.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient required a ct scan to determine if the fractured stent remained in the patient after withdrawal of the delivery system.The patient did not experience any adverse effects as a result of 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: 9374602
• MDR Text Key: 168580447
• Report Number: 3001845648-2019-00627
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384634
• UDI-Public: (01)10827002384634(17)210115(10)C1613840
• Combination Product (y/n): N
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: G38463
• Device Catalogue Number: ZISV6-35-125-6-40-PTX
• Device Lot Number: C1613840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/09/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention