MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT

Model Number G57453

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Nio stent, iliac.Product code: qan.Pma/510(k) #: p200023 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: while trying to deploy the stent, the stent would not unsheathe.Removed from the body and flushed it, reattempted and it would not deploy.The procedure was completed using a competitor stent.Patient outcome was good.Patient outcome: did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? no.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? na.Patient/event info - notes: note: pt age: (b)(6).Where was the access site? right femoral vein.What was the patient¿s anatomy? no notable anatomy; target location tortuous.What was the target location for the stent? left subclavian vein.Was the target location severely calcified or tortuous? tortuous.Was the device flushed prior to use? yes.Were there any difficulties deploying the stent? would not unsheathe.Was the stent fully deployed before removing the delivery system from the patient? na.What other devices were used in the procedure? thrombectomy device, balloon 8x60 (non cook), collide advantage, 8x70 ansel sheath.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? no.Was the stent eventually deployed? the dm did mess with the device and was able to pin pull and it began to unsheathe, but he ceased to.Was pre-dilatation conducted before stent deployment? yes.Was the handle pulled toward the hub while the delivery system remained stationary during deployment? yes.Information requested by cirl on 19dec2020: (answered during intake, see above and patient details) are images of the device or procedure available? no.Did the patient have pre-existing conditions? ni.Please describe the native state of the vessel? what was the patient¿s anatomy? no notable anatomy; target location tortuous was post dilation performed after the plac.Ement of the stent? n/a - per event description, complaint device was not placed.Was pre-dilation performed ahead of placement of the stent? yes.What was the target location for the stent?left subclavian vein.Information requested by cirl sent via email on 29dec2020: ar 29dec2020 was a stent previously placed during previous procedures? was the device used percutaneously? where on the patient was the percutaneous access site? was the access site jugular or femoral? if other, please specify: what disease pathology was being treated? may-thurner syndrome (mts), acute or chronic obstruction, restenosis, other? if other, please specify was the lesion approached via contralateral or ipsilateral? was the device flushed through both flushing ports before the procedure, as per ifu? details of the wire guide used (name, diameter, hydrophilic)? was resistance encountered when advancing the wire guide to the target location? was resistance encountered when advancing the delivery system to the target location? if resistance was met, how did the physician address this? did the tip of the delivery system cross the target location? did the user push the hub during deployment? did the user remove slack in the delivery system before deployment, per ifu? was the delivery system damaged/kinked/twisted during deployment? were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? information received on 29dec2020: ar 29dec2020.No.Yes.Rfv.Rfv.Chronic obstructive.Na.Lesion was in left subclavian vein.The device was definitely flushed through the lumen but the tech was not 100% sure if the flushed the stent deployment portion.Wire was glide advantage with the glide portion distal to the stent and not involved in deployment.No.No.Yes.No.Yes.No.No.

Manufacturer Narrative

D2) nio stent, iliac.D2b) product code: qan.Pma/510(k) #: p200023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report being submitted due to the device being returned and lab evaluation being completed at cirl on (b)(6) 2021.As reported to customer relations: while trying to deploy the stent, the stent would not unsheathe.Removed from the body and flushed it, reattempted and it would not deploy.The procedure was completed using a competitor stent.Patient outcome was good.Patient outcome: did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? no.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? na.Patient/event info - notes: note: pt age: 60s.Where was the access site? right femoral vein.What was the patient¿s anatomy? no notable anatomy; target location tortuous.What was the target location for the stent? left subclavian vein.Was the target location severely calcified or tortuous? tortuous.Was the device flushed prior to use? yes.Were there any difficulties deploying the stent? would not unsheathe.Was the stent fully deployed before removing the delivery system from the patient? na.What other devices were used in the procedure? thrombectomy device, balloon 8x60 (non cook), collide advantage, 8x70 ansel sheath.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? no.Was the stent eventually deployed? the dm did mess with the device and was able to pin pull and it began to unsheathe, but he ceased to.Was pre-dilatation conducted before stent deployment? yes.Was the handle pulled toward the hub while the delivery system remained stationary during deployment? yes.Information requested by cirl on (b)(6) 2020: (answered during intake, see above and patient details).Are images of the device or procedure available? no.Did the patient have pre-existing conditions? ni.Please describe the native state of the vessel? what was the patient¿s anatomy? no notable anatomy; target location tortuous.Was post dilation performed after the placement of the stent? n/a - per event description, complaint device was not placed.Was pre-dilation performed ahead of placement of the stent? yes.What was the target location for the stent?left subclavian vein.Information requested by cirl sent via email on 29dec2020: ar (b)(6) 2020.1.Was a stent previously placed during previous procedures? 2.Was the device used percutaneously? 3.Where on the patient was the percutaneous access site? 4.Was the access site jugular or femoral? a.If other, please specify: 5.What disease pathology was being treated? may-thurner syndrome (mts), acute or chronic obstruction, restenosis, other? 6.If other, please specify 7.Was the lesion approached via contralateral or ipsilateral? 8.Was the device flushed through both flushing ports before the procedure, as per ifu? 9.Details of the wire guide used (name, diameter, hydrophilic)? 10.Was resistance encountered when advancing the wire guide to the target location? 11.Was resistance encountered when advancing the delivery system to the target location? a.If resistance was met, how did the physician address this? 12.Did the tip of the delivery system cross the target location? 13.Did the user push the hub during deployment? 14.Did the user remove slack in the delivery system before deployment, per ifu? 15.Was the delivery system damaged/kinked/twisted during deployment? 16.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? information received on 29dec2020: ar (b)(6) 2020.1.No.2.Yes.3.Rfv.4.Rfv.5.Chronic obstructive.6.Na.7.Lesion was in left subclavian vein.8.The device was definitely flushed through the lumen but the tech was not 100% sure if she flushed the stent deployment portion.9.Wire was glide advantage with the glide portion distal to the stent and not involved in deployment.10.No.11.No.12.Yes.13.No.14.Yes.15.No.16.No.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

D2) nio stent, iliac.D2b) product code: qan.Pma/510(k) #: p200023.Device evaluation the zvt7-35-120-16-60 device of lot number c1769760 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.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 26 january 2021.The returned device lab examination findings and observations can be referred through attached photos on evaluation of the device approx.1.5 cm of the stent was observed to be partially deployed from the distal end of the outer sheath.The red safety lock was not returned with the device.The device flushed as expected and a 0.035¿ wire guide passed through the device without issue.The stent was deployed during the lab evaluation and no damage was observed on the stent.Document review prior to distribution zvt7-35-120-16-60 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 zvt7-35-120-16-60 of lot number c1769760 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 c1769760.It should be noted that the instructions for use (ifu0047-5) states the following: ¿the zilver vena venous stent is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.¿ there is evidence to suggest the user did not follow the ifu.Root cause review a definitive root cause of off-label was identified in the laboratory.From the information provided it is known that the device was used in the left subclavian vein.As per the ifu the device is intended for use in the iliofemoral veins.Additional information provided by after the lab evaluation of the device confirmed that the stent did not partially deploy inside the patient but when the device had been removed from the patient and the district manager (dm) was examining the device and attempting to deploy it.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.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11095910
• MDR Text Key: 244421008
• Report Number: 3001845648-2020-00989
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574530
• UDI-Public: (01)10827002574530(17)231020(10)C1769760
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2023
• Device Model Number: G57453
• Device Catalogue Number: ZVT7-35-120-16-60
• Device Lot Number: C1769760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 12/03/2020; 12/03/2020
• Supplement Dates FDA Received: 02/24/2021; 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1