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

Catalog Number ZISV6-35-125-7.0-40-PTX

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Access was gained from right fa to the lesion of left proximal stenosis sfa.The patient's anatomical forms were suitable for the procedure.The physician attempted to deploy zilver ptx drug-eluting peripheral stent ((7mmx12cm)-c1417804) at left proximal sfa, the thumbwheel started to spin around, then the stent could not be deployed completely with 2cm undeployed stent.So, the handle was disassembled and he pulled the sheath which presumed be connected to the retraction sheath so the stend was deployed.Wnen the physician attempted to remove zilver ptx drug-eluting peripheral stent ((7mmx4cm)-c1396712) from the package, he noticed that the plastic protactor tube outside of the sheath was kinked.Then, he removed the delivery system from the plastic protector tube and it was confirmed that the device got kinked too.Therefore, another lot # of the same rpn was used instead to complete the procedure.There have been no adverse effect to the patient reported.

Event Description

This correction mdr is being submitted to update the investigation details.After the lab evaluation and mdr reports were submitted it was discovered that the incorrect device was evaluated due to a mix up in labeling by the return sender.No change to failure mode, root cause or risk assessment.It is confirmed that the device for this complaint is zisv6-35-125-7.0-40-ptx device of lot c1396712.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).Pma/510(k) # p100022/s014.Problem statement: "access was gained from right fa to the lesion of left proximal stenosis sfa.The patient's anatomical forms were suitable for the procedure.The physician attempted to deploy zilver ptx drug-eluting peripheral stent ((7mmx12cm)-c1417804) at left proximal sfa, the thumbwheel started to spin around, then the stent could not be deployed completely with 2cm undeployed stent (pr209269).So, the handle was disassembled and he pulled the sheath which presumed be connected to the retraction sheath so the stent was deployed.When the physician attempted to remove zilver ptx drug-eluting peripheral stent ((7mmx4cm)-c1396712) from the package, he noticed that the plastic protector tube outside of the sheath was kinked.Then, he removed the delivery system from the plastic protector tube and it was confirmed that the device got kinked too.Therefore, another lot # of the same rpn was used instead to complete the procedure (pr209275).There have been no adverse effects to the patient reported." ¿physician's comment the first delivery system advanced over the 0.014 inch wire guide near the lesion, then the wire guide was replaced with 0.035 inch.I felt little bit of uncomfortable feeling during advancement over the 0.035 inch wire guide.Also, when the delivery system was removed from the tray, the assistant physician removed roughly.So that may be affect to the complaint.However, second device was kinked from the first, i wonder if the first device was also kinked from the first.¿ device evaluation: the zisv6-35-125-7.0-40-ptx device of lot c1396712 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.From customer testimony, it is known that the physician disassembled the device handle, but did not cut any portion of the device catheters.The patient¿s anatomy was not severely calcified or tortuous, but some slight calcification was observed.At the time of investigation, there are no images of the procedure available.The investigation will be updated if images are provided and evaluated.The device related to this occurrence underwent a laboratory evaluation on the 7th december 2017.On evaluation of the returned device, it was observed that the device was returned with a 0.014¿ diameter wire guide still loaded in the device lumen, and without the stent.The proximal inner was broken in three pieces, with evidence of tearing or cutting.The distal white tip was bent.The device handle was opened, and the stent retraction wire was found to be separated from the stent retraction sheath.There was no evidence of kinks or tactile damage on the sheath.Complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was found to be separated from the stent sheath.The complaint originally stated that the complaint device was a zisv6-35-125-7.0-120-ptx device of lot number c1417804.The customer was contacted to confirm if the correct device was returned.From customer testimony, it is confirmed that the device for this complaint is zisv6-35-125-7.0-40-ptx device of lot c1396712.It may be noted that the customer provided images of the device, but these are mislabeled with the incorrect complaint numbers.Possible causes for this occurrence could include the use of a non-recommended wire guide.From the lab evaluation, it was found that the complaint device was used with a 0.014¿ diameter wire guide.The non-recommended wire guide could have provided insufficient support during deployment and caused or contributed to the stent retraction wire separating from the stent retraction sheath.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.A capa has been initiated to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.It can be noted that as per the product insert: ¿to ensure adequate support of the system, introduce a 0.89mm (0.035 inch) guide wire through the sheath across the distal segment of the target lesion.¿ ¿under fluoroscopy, advance the delivery system over a 0.89-mm (0.035-inch) guide wire through the sheath until the distal end stent marker goes beyond the target lesion." document review: prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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.Summary: complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was found to be separated from the stent sheath.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

Mdr is being submitted based on the device malfunction precedence: 'thumbwheel malfunctions".Access was gained from right fa to the lesion of left proximal stenosis sfa.The patient's anatomical forms were suitable for the procedure.The physician attempted to deploy zilver ptx drug-eluting peripheral stent ((7mmx12cm)-c1417804) at left proximal sfa, the thumbwheel started to spin around, then the stent could not be deployed completely with 2cm undeployed stent.So, the handle was disassembled and he pulled the sheath which presumed be connected to the retraction sheath so the stend was deployed.When the physician attempted to remove zilver ptx drug-eluting peripheral stent ((7mmx4cm)-c1396712) from the package, he noticed that the plastic protactor tube outside of the sheath was kinked.Then, he removed the delivery system from the plastic protector tube and it was confirmed that the device got kinked too.Therefore, another lot # of the same rpn was used instead to complete the procedure.There have been no adverse effect to the patient reported.

Manufacturer Narrative

(b)(4).Exemption number: e2016031 (b)(4).Pma/510(k) # p100022/s014 "access was gained from right fa to the lesion of left proximal stenosis sfa.The patient's anatomical forms were suitable for the procedure.The physician attempted to deploy zilver ptx drug-eluting peripheral stent((7mmx12cm)-c1417804) at left proximal sfa, the thumbwheel started to spin around, then the stent could not be deployed completely with 2cm undeployed stent ((b)(4)).So, the handle was disassembled and he pulled the sheath which presumed be connected to the retraction sheath so the stent was deployed.When the physician attempted to remove zilver ptx drug-eluting peripheral stent ((7mmx4cm)-c1396712) from the package, he noticed that the plastic protector tube outside of the sheath was kinked.Then, he removed the delivery system from the plastic protector tube and it was confirmed that the device got kinked too.Therefore, another lot # of the same rpn was used instead to complete the procedure ((b)(4)).There have been no adverse effects to the patient reported." physician's comment: "the first delivery system advanced over the 0.014 inch wire guide near the lesion, then the wire guide was replaced with 0.035 inch.I felt little bit of uncomfortable feeling during advancement over the 0.035 inch wire guide.Also, when the delivery system was removed from the tray, the assistant physician removed roughly.So that may be affect to the complaint.However, second device was kinked from the first, i wonder if the first device was also kinked from the first.¿ the zisv6-35-125-7.0-120-ptx device of lot number c1417804 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.From customer testimony, it is known that the physician disassembled the device handle, but did not cut any portion of the device catheters.The patient¿s anatomy was not severely calcified or tortuous, but some slight calcification was observed.At the time of investigation, there are no images of the procedure available.The investigation will be updated if images are provided and evaluated.The device related to this occurrence underwent a laboratory evaluation on the 7th december 2017.On evaluation of the returned device, it was observed that the device was returned with a 0.014¿ diameter wire guide still loaded in the device lumen, and without the stent.The proximal inner was broken in three pieces, with evidence of tearing or cutting.The distal white tip was bent.The device handle was opened, and the stent retraction wire was found to be separated from the stent sheath.There was no evidence of kinks or tactile damage on the sheath.Complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was found to be separated from the stent sheath.Possible causes for this occurrence could include the use of a non-recommended wire guide.From the lab evaluation, it was found that the complaint device was used with a 0.014¿ diameter wire guide.The non-recommended wire guide could have provided insufficient support during deployment and caused or contributed to the stent retraction wire separating from the stent retraction sheath.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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.Complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was found to be separated from the stent sheath.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 follow up mdr is being submitted to update the investigation details.The lot number and additional information we're received.It is confirmed that the device for this complaint is zisv6-35-125-7.0-40-ptx device of lot c1396712.Access was gained from right fa to the lesion of left proximal stenosis sfa.The patient's anatomical forms were suitable for the procedure.The physician attempted to deploy zilver ptx drug-eluting peripheral stent((7mmx12cm)-c1417804) at left proximal sfa, the thumbwheel started to spin around, then the stent could not be deployed completely with 2cm un deployed stent ((b)(4)).So, the handle was disassembled and he pulled the sheath which presumed be connected to the retraction sheath so the stent was deployed.When the physician attempted to remove zilver ptx drug-eluting peripheral stent ((7mmx4cm)-c1396712)from the package, he noticed that the plastic protector tube outside of the sheath was kinked.Then, he removed the delivery system from the plastic protector tube and it was confirmed that the device got kinked too.Therefore, another lot # of the same rpn was used instead to complete the procedure.There have been no adverse effect to the patient reported.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).Pma/510(k) # p100022/s014.Device evaluation the zisv6-35-125-7.0-40-ptx device of lot c1396712 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.From customer testimony, it is known that the physician disassembled the device handle, but did not cut any portion of the device catheters.The patient¿s anatomy was not severely calcified or tortuous, but some slight calcification was observed.At the time of investigation, images of the procedure have not yet been provided.The customer also confirmed that the device was advanced over a 0.014" diameter wire guide, and the wire guide was swapped for a 0.035" diameter wire prior to deployment.The investigation will be updated when images are provided and evaluated.The device related to this occurrence underwent a laboratory evaluation on the (b)(6) 2017.On evaluation of the returned device, it was observed that the device was returned with a 0.014¿ diameter wire guide, and without the stent.The proximal inner was broken in three pieces, with evidence of tearing or cutting.The distal white tip was bent.The device handle was opened, and the stent retraction wire was found to be separated from the stent retraction sheath.There was no evidence of kinks or tactile damage on the sheath.Complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was found to be separated from the stent sheath.Possible causes for this occurrence could include the use of a non-recommended wire guide.From customer testimony, the complaint device was advanced over a 0.014¿ diameter wire guide, which was swapped for a 0.035" diameter wire prior to deployment.The non-recommended wire guide could have provided insufficient support during advancement, potentially leading to the damaged proximal inner which could have caused or contributed to the stent retraction wire separating from the stent retraction sheath.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.A capa has been initiated to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.It can be noted that as per the product insert: ¿to ensure adequate support of the system, introduce a 0.89mm (0.035 inch) guide wire through the sheath across the distal segment of the target lesion.¿ ¿under fluoroscopy, advance the delivery system over a 0.89-mm (0.035-inch) guide wire through the sheath until the distal end stent marker goes beyond the target lesion." document review: prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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 c1396712.Summary: complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was found to be separated from the stent sheath.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.

• 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: 7128711
• MDR Text Key: 96033963
• Report Number: 3001845648-2017-00616
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352862
• UDI-Public: (01)10827002352862(17)190712(10)C1396712
• 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,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-7.0-40-PTX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2017
• Event Location: Hospital
• Date Manufacturer Received: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR