MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number G43858

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problems No Information (3190); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.A preliminary investigation has been conducted and has found no reason to believe there has been a device mix-up.The only image provided was of a removeable label that may have been accidentally applied to a previously shipped 8-40 to this customer.Investigation is ongoing but at this point it is assumed to be user error and not a device label mix up.

Event Description

Per rep - 19oct2020 - please find the barcode for an 8x80 stent that was used by c43414-4 last week.I was not present at the case but apparently the stent was mis-labeled as the stent was in fact an 8-40 in length and not an 8-80.No additional procedures were needed.I have copied (b)(6), the rt on this message.She was not present when the incident occurred however she is the point of contact for this account.Per rep - 19oct2020 - they did implant it.I don¿t believe they realized it was the wrong size until they implanted it.Per customer - 20oct2020 - i was not present for the case, but per the doctor the stent was deployed and then it was noticed that it was shorter.It does not seem likely that it compressed or shortened due to a kissing stent being deployed simultaneously that should have been shorter (60mm) and ended up looking longer.No, the stent was not long enough and two additional stents were required to achieve a satisfactory result.Patient outcome: did any unintended section of the device remain inside the patient¿s body? -unknown if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? -unknown.Did the patient require any additional procedures due to this occurrence? -no if yes, please describe.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? -unknown.Has the complainant reported that the product caused or contributed to the adverse effects? -unknown.Please specify adverse effects and provide details.Patient / event info - notes: 1.0 examples of rpn prefixes (but not limited to): zib5, zib6, ziv5, zisv6, zvt7, ziv6.General questions for complaint occurring during use, request the following: where was the access site? what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.What was the target location for the stent? was the target location severely calcified or tortuous? was the device flushed prior to use? were there any difficulties deploying the stent? was the stent fully deployed before removing the delivery system from the patient? what other devices were used in the procedure? please provide manufacturer, model, brand, and size if possible.Were any additional procedures necessary as a result of this event? can any photos, images, or reports of the procedure or device be provided? please review following ¿failure¿ modes with contact to determine if additional questions apply.If the event involves thombosis, restenosis, and/or occlusion, request the following: -n/a.If the event involved claudication / pain, request the following: -n/a.If the event involves stent shortening, request the following: -n/a.If the event involves sheath separation, request the following: -n/a.If the event involving deployment difficulties, request the following: -n/a.If the event that involve device stuck on wire guide, difficult to advance / remove delivery system and/or wire guide, request the following: -n/a.

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.A preliminary investigation has been conducted and has found no reason to believe there has been a device mix-up.The only image provided was of a removeable label that may have been accidentally applied to a previously shipped 8-40 to this customer.Investigation is ongoing but at this point it is assumed to be user error and not a device label mix up.

Event Description

Supplemental report being submitted due to additional information being received on 07-dec-2020 regarding, date of event, patient information, type of procedure, intervention, patient outcome and patient/event info-notes.This report is related to 3001845648-2020-00875.Per rep - 19oct2020- please find the barcode for an 8x80 stent that was used by (b)(6) last week.I was not present at the case but apparently the stent was mis-labeled as the stent was in fact an 8-40 in length and not an 8-80.No additional procedures were needed.I have copied laura, the rt on this message.She was not present when the incident occurred however she is the point of contact for this account.Per rep - 19oct2020 - they did implant it.I don¿t believe they realized it was the wrong size until they implanted it.Per customer - (b)(6) 2020 - i was not present for the case, but per the doctor the stent was deployed and then it was noticed that it was shorter.It does not seem likely that it compressed or shortened due to a kissing stent being deployed simultaneously that should have been shorter (60mm) and ended up looking longer.No, the stent was not long enough and two additional stents were required to achieve a satisfactory result.Patient outcome: did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.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.Patient / event info - notes: 1.0 examples of rpn prefixes (but not limited to): zib5, zib6, ziv5; zisv6, zvt7, ziv6.1.1 general questions for complaint occurring during use, request the following: 1.2 where was the access site? common femoral artery.1.3 what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.Looks somewhat calcified, again, was not present for procedure.1.4 what was the target location for the stent? iliac artery bifurcation.Was the target location severely calcified or tortuous? looks somewhat calcified, again, was not present for procedure.1.5 was the device flushed prior to use? yes.1.6 were there any difficulties deploying the stent? 1.7 was the stent fully deployed before removing the delivery system from the patient? 1.8 what other devices were used in the procedure? 6f boston scientific super sheath 11cm &.035 bentson.Please provide manufacturer, model, brand, and size if possible.6f boston scientific super sheath 11cm &.035 bentson.1.9 were any additional procedures necessary as a result of this event? no.1.10 can any photos, images, or reports of the procedure or device be provided? yes, images.2.0 please review following ¿failure¿ modes with contact to determine if additional questions apply.2.1 if the event involves thombosis, restenosis, and/or occlusion, request the following: n/a.2.2 if the event involved claudication / pain, request the following: n/a.2.3 if the event involves stent shortening, request the following: n/a.2.4 if the event involves sheath separation, request the following: n/a.2.5 if the event involving deployment difficulties, request the following: n/a.2.6 if the event that involve device stuck on wire guide, difficult to advance / remove delivery system and/or wire guide, request the following: n/a.Provided by customer 07dec2020 (b)(6) 2020.General questions: what was the date of the event? (b)(6) 2020.Will your facility be reporting this event to the fda? unknown; assume not.Would you like a no charge replacement or credit to be issued? unsure how this works, with consignment.Either is acceptable.Are patient demographics (age, gender, weight and pre-existing conditions) available? 57y/o male 117lbs.What type of procedure was being performed? arterial angiogram with angioplasty and stenting ¿ iliac artery.Did this problem create the need for any medical or surgical interventions? additional stent was deployed.Did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Product specific additional questions: 1.What was the target location for the complaint device? iliac artery bifurcation.2.Was the device used percutaneously? yes.3.Which artery was the stent to be placed in? iliac.4.Was the approach ipsilateral or contralateral? both accessed for kissing balloons.5.If contralateral, was the bifurcation angle tight? unknown ¿ was not present for procedure.6.Where on the patient was the percutaneous access site? common femoral artery.7.Details of access sheath used (name, fr size, length)? 6f boston scientific super sheath 11cm.8.Was the device flushed through both flushing port before the procedure, as per ifu? yes.9.Details of the wire guide used (name, diameter, hyrdophyllic)?.035 bentson.10.Was the patient's anatomy tortuous or calcified? looks somewhat calcified, again, was not present for procedure.11.Was resistance encountered when advancing the wire guide or delivery system to the target location? how did the physician deal with this resistance? unknown.12.Was pre-dilation performed ahead of placement of the stent? yes.13.Was post-dilation performed after the placement of the stent? yes.15.Are images of the device of procedure available? yes.16.Did the user pull the handle toward the hub during deployment and delivery system was not pushed during deployment? unknown.17.What artery was the stent placed in? common iliac.18.How did the user confirm the length of the stent after stent placement? a stent was placed simultaneously (bifurcation, kissing stents) that was 60mm long and visualization showed it was longer than the stent in.

Manufacturer Narrative

Annex g: g04113 - stent.Investigation is still underway.

Event Description

Image review completed on 04-feb2021: impression: although a zilver stent with an implanted length of at most 28.67mm is confirmed, the assertion that the stent was a ziv6-35-40-8-80 in a ziv6-35-80-8-80 package is not confirmed.It is much more likely that the stent was implanted concertinaed and or telescoped.It is possible given the loss of wire access that this occurred or was further exacerbated during attempted repeat cannulation.Findings consistent with either a severe concertinaed or telescoped stent cannot be distinguished from calcification on the provided imaging.During kissing stent implantation, both stents are positioned and adjusted under fluoroscopy before simultaneous deployment.This scrutiny would have rendered obvious any shorter than expected stent prior to deployment.A review of the literature failed to find peer reviewed data comparing kissing self-expanding stents, balloon expandable stents, covered stents, or a combination of stent types for this type of lesion.However, kissing self-expanding stenting of this heavily calcified long distal aorto-iliac stenosis with mound-like plaque would be an uncommon approach.The more common approach would be two balloon expandable kissing iliac stents with or without a covered or balloon expandable aortic stent.The heavily calcified plaque with persistent stenosis, the adjacent stent, and the left cia occlusion are risk factors for concertinaed deployment.Per rep - 19oct2020- please find the barcode for an 8x80 stent that was used by c43414-4 last week.I was not present at the case but apparently the stent was mis-labeled as the stent was in fact an 8-40 in length and not an 8-80.No additional procedures were needed.I have copied (b)(6), the rt on this message.She was not present when the incident occurred however she is the point of contact for this account.Per rep - 19oct2020- they did implant it.I don¿t believe they realized it was the wrong size until they implanted it.Per customer - 20oct2020- i was not present for the case, but per the doctor the stent was deployed and then it was noticed that it was shorter.It does not seem likely that it compressed or shortened due to a kissing stent being deployed simultaneously that should have been shorter (60mm) and ended up looking longer.No, the stent was not long enough and two additional stents were required to achieve a satisfactory result.Patient outcome: did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.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.Patient / event info - notes: 1.0 examples of rpn prefixes (but not limited to): zib5, zib6, ziv5.Zisv6, zvt7, ziv6.General questions for complaint occurring during use, request the following: where was the access site? common femoral artery.What was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.Looks somewhat calcified, again, was not present for procedure.What was the target location for the stent? iliac artery bifurcation.Was the target location severely calcified or tortuous? looks somewhat calcified, again, was not present for procedure.Was the device flushed prior to use? yes.Were there any difficulties deploying the stent? was the stent fully deployed before removing the delivery system from the patient? what other devices were used in the procedure? -6f boston scientific super sheath 11cm &.035 bentson.Please provide manufacturer, model, brand, and size if possible.6f boston scientific super sheath 11cm &.035 bentson.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? yes, images.Please review following ¿failure¿ modes with contact to determine if additional questions apply.If the event involves thombosis, restenosis, and/or occlusion, request the following: n/a.If the event involved claudication / pain, request the following: n/a.If the event involves stent shortening, request the following: n/a.If the event involves sheath separation, request the following: n/a.2.5 if the event involving deployment difficulties, request the following: n/a.If the event that involve device stuck on wire guide, difficult to advance / remove delivery system and/or wire guide, request the following: n/a.Provided by customer -(b)(6) 2020 -m.S general questions: what was the date of the event? (b)(6) 2020.Will your facility be reporting this event to the fda? unknown; assume not.Would you like a no charge replacement or credit to be issued? unsure how this works, with consignment.Either is acceptable.Are patient demographics (age, gender, weight and pre-existing conditions) available? 57y/o male 117lbs.What type of procedure was being performed? arterial angiogram with angioplasty and stenting ¿ iliac artery.Did this problem create the need for any medical or surgical interventions? additional stent was deployed.Did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Product specific additional questions: what was the target location for the complaint device? iliac artery bifurcation.Was the device used percutaneously? yes.Which artery was the stent to be placed in? iliac.Was the approach ipsilateral or contralateral? both accessed for kissing balloons.If contralateral, was the bifurcation angle tight? unknown ¿ was not present for procedure.Where on the patient was the percutaneous access site? common femoral artery.Details of access sheath used (name, fr size, length)? 6f boston scientific super sheath 11cm.Was the device flushed through both flushing port before the procedure, as per ifu? yes.Details of the wire guide used (name, diameter, hyrdophyllic)?.035 bentson.Was the patient's anatomy tortuous or calcified? looks somewhat calcified, again, was not present for procedure.Was resistance encountered when advancing the wire guide or delivery system to the target location? how did the physician deal with this resistance? unknown.Was pre-dilation performed ahead of placement of the stent? yes.Was post-dilation performed after the placement of the stent? yes.Are images of the device of procedure available? yes.Did the user pull the handle toward the hub during deployment and delivery system was not pushed during deployment? unknown.What artery was the stent placed in? common iliac.How did the user confirm the length of the stent after stent placement? a stent was placed simultaneously (bifurcation, kissing stents) that was 60mm long and visualization showed it was longer than the stent in question.

Event Description

Final mdr report being submitted due to confirmation of off-label use by clinical advisor for stents being placed in kissing fashion on (b)(6) 2021 and subsequent completion of the investigation on 03-dec-2021.

Manufacturer Narrative

Device evaluation: the ziv6-35-80-8-80 device of lot number c1735302 involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution ziv6-35-80-8-80 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 ziv6-35-80-8-80 of lot number c1735302 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 c1735302.It should be noted that the instructions for use (ifu0043-9) states the following: ¿the zilver vascular stent is intended for use as an adjunct to percutaneous transluminal angioplasty (pta) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm¿.As the ifu does not contain instructions for the placement of zilver 635 vascular self-expanding stents in a kissing fashion, this is considered off-label use.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: 1.Although a zilver stent with an implanted length of at most 28.67mm is confirmed, the assertion that the stent was a ziv6-35-40-8-80 in a ziv6-35-80-8-80 package is not confirmed.2.It is much more likely that the stent was implanted concertinaed and or telescoped.It is possible given the loss of wire access that this occurred or was further exacerbated during attempted repeat cannulation.Findings consistent with either a severe concertinaed or telescoped stent cannot be distinguished from calcification on the provided imaging.3.During kissing stent implantation, both stents are positioned and adjusted under fluoroscopy before simultaneous deployment.This scrutiny would have rendered obvious any shorter than expected stent prior to deployment.4.A review of the literature failed to find peer reviewed data comparing kissing self-expanding stents, balloon expandable stents, covered stents, or a combination of stent types for this type of lesion.However, kissing self-expanding stenting of this heavily calcified long distal aorto-iliac stenosis with mound-like plaque would be an uncommon approach.The more common approach would be two balloon expandable kissing iliac stents with or without a covered or balloon expandable aortic stent.5.The heavily calcified plaque with persistent stenosis, the adjacent stent, and the left cia occlusion are risk factors for concertinaed deployment.Root cause review: a definitive root cause of off label use was identified from the available information as the ifu does not contain instructions on the placement of these stents in a kissing fashion and as testing has not been undertaken using this deployment method, this is considered off-label use.It is not possible to determine how the device will function when used outside of its validated state.Furthermore, according to the image review the patients anatomy was heavily calcified and the left cia showed evidence of occlusion.Therefore, it is possible that the patients difficult anatomy may have also contributed to the compression of the stent.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

Pma510k #p050017 s002 and s003.Device evaluation: the ziv6-35-80-8-80 device of lot number c1735302 involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution ziv6-35-80-8-80 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 ziv6-35-80-8-80 of lot number c1735302 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 c1735302.It should be noted that the instructions for use (ifu0043-9) states the following: ¿the zilver vascular stent is intended for use as an adjunct to percutaneous transluminal angioplasty (pta) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm¿.There is evidence to suggest the user did not follow the ifu.From the information available it is known that the stents were placed in the distal aorta which is not the intended location for these devices and thus considered off label use.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: 1.Although a zilver stent with an implanted length of at most 28.67mm is confirmed, the assertion that the stent was a ziv6-35-40-8-80 in a ziv6-35-80-8-80 package is not confirmed.2.It is much more likely that the stent was implanted concertinaed and or telescoped.It is possible given the loss of wire access that this occurred or was further exacerbated during attempted repeat cannulation.Findings consistent with either a severe concertinaed or telescoped stent cannot be distinguished from calcification on the provided imaging.3.During kissing stent implantation, both stents are positioned and adjusted under fluoroscopy before simultaneous deployment.This scrutiny would have rendered obvious any shorter than expected stent prior to deployment.4.A review of the literature failed to find peer reviewed data comparing kissing self-expanding stents, balloon expandable stents, covered stents, or a combination of stent types for this type of lesion.However, kissing self-expanding stenting of this heavily calcified long distal aorto-iliac stenosis with mound-like plaque would be an uncommon approach.The more common approach would be two balloon expandable kissing iliac stents with or without a covered or balloon expandable aortic stent.5.The heavily calcified plaque with persistent stenosis, the adjacent stent, and the left cia occlusion are risk factors for concertinaed deployment.Root cause review: a definitive root cause of off label use was identified from the available information.The stents were placed in the distal aorta, which is not the intended location of this device and thus considered off label use.The user has not complied with the requirements of the ifu with respect to the intended use of the device.It should be noted that, as the device was used outside of their validated state and/or against the instructions provided in the ifu, it is not possible to predict how the devices will perform or function.Furthermore, according to the image review the patients anatomy was heavily calcified and the left cia showed evidence of occlusion.Therefore, it is possible that the patients difficult anatomy may have also contributed to the compression of the stent.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.

Event Description

Correction report being submitted due the updates made to the root cause in investigation evaluation and summary of investigation on 20 mar 2023.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 10853780
• MDR Text Key: 219842933
• Report Number: 3001845648-2020-00873
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002438580
• UDI-Public: (01)10827002438580(17)230615(10)C1735302
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: G43858
• Device Catalogue Number: ZIV6-35-80-8-80
• Device Lot Number: C1735302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/09/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 10/19/2020; 10/19/2020; 10/19/2020; 10/19/2020
• Supplement Dates FDA Received: 12/16/2020; 03/03/2021; 12/16/2021; 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 53 KG