MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 518 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number G43778

Device Problems Premature Activation (1484); Improper or Incorrect Procedure or Method (2017)

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

Pma/510(k) #: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Plan: placing ziv5-18-125-7-80 in the right eia by left brachial approach and placing ziv6-35-80-10-80 in the right cia by right femoral approach.After removing the ziv5-18-125-7-80 from the packaging, the physician attempted to flush the delivery system from the side-arm flushing port with the 1mm syringe which was included in the packaging.However, because saline did not exit the distal tip but returned to the syringe, the physician flushed only through the wire lumen and continued to use the device ((b)(4)).The physician had a difficulty in pulling the handle due to strong resistance when attempting to deploy the stent.He applied some more force, then the stent popped out a little, but after that, it could be deployed smoothly and placed in the right eia successfully ((b)(4)).After that, the physician attempted to place the ziv6-35-80-10-80, but he encountered slight resistance during deployment of the stent.The approximately 4cm of the stent was deployed with elongation, which might have been effected by the deployment difficulty which the physician felt during deployment.However, after deploying the first 4cm (elongated part), the stent could be deployed normally and the procedure was completed ((b)(4)).There have been no adverse effects to the patient reported.Patient outcome: there have been no adverse effects to the patient reported.Patient/event info - notes: request from the rep: please complete the investigation with possible causes as soon as possible since the physician wants to know the cause.Additional information: prefix ziv5/ziv6/.Was the device used percutaneously? (yes).Which artery was the stent to be placed in? cia (ziv6:pr315914) / eia (ziv5: pr).Was the approach ipsilateral or contralateral? (ipsilateral) (ziv6: (b)(4))(ziv5= left brachial approach).If contralateral, was the bifurcation angle tight? where on the patient was the percutaneous access site? ziv5: left brachial & ziv6: right fa.Details of access sheath used (name, fr size, length)? elbow: parent 6fr 88 ipsilateral:parent 6fr approximately 23cm manufactured by medikit.Was the device flushed through both flushing port before the procedure, as per ifu? (yes).Details of the wire guide used (name, diameter, hyrdophyllic)? jupiter fc3 by boston scientific.Was the patient's anatomy tortuous or calcified? (tortuosity:no calification:yes).Was resistance encountered when advancing the wire guide or delivery system to the target location? (no).How did the physician deal with this resistance? was pre-dilation performed ahead of placement of the stent? (yes).Was post-dilation performed after the placement of the stent? (yes).Did the tip of the delivery system cross the target location? (yes).Are images of the device of procedure available? (no).Did the user pull the handle toward the hub during deployment and delivery system was not pushed during deployment? (yes).Prefix ziv6-ptx/zisv6-ptx: n/a.Thrombosis: n/a.Restenosis: n/a.Occlusion: n/a.Worsen claudication/pain: n/a.Stent shortening: n/a.Difficulty advancing over the wire guide: n/a.Sheath separation: n/a.Deployment difficulty was the device flushed through the flushing port before the procedure, as per ifu? (yes).Was the stent fully deployed in the patient? (yes).Was the target site severely calcified? (yes).Was patient anatomy tortuous? (no).Was pre dilatation conducted before stent deployment? (yes).Was the delivery system kinked or twisted during deployment? (no).

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.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 complaint device being evaluated at cirl plan: placing ziv5-18-125-7-80 in the right eia by left brachial approach and placing ziv6-35-80-10-80 in the right cia by right femoral approach.After removing the ziv5-18-125-7-80 from the packaging, the physician attempted to flush the delivery system from the side-arm flushing port with the 1mm syringe which was included in the packaging.However, because saline did not exit the distal tip but returned to the syringe, the physician flushed only through the wire lumen and continued to use the device (pr(b)(4)).The physician had a difficulty in pulling the handle due to strong resistance when attempting to deploy the stent.He applied some more force, then the stent popped out a little, but after that, it could be deployed smoothly and placed in the right eia successfully (pr(b)(4)).After that, the physician attempted to place the ziv6-35-80-10-80, but he encountered slight resistance during deployment of the stent.The approximately 4cm of the stent was deployed with elongation, which might have been effected by the deployment difficulty which the physician felt during deployment.However, after deploying the first 4cm (elongated part), the stent could be deployed normally and the procedure was completed (pr(b)(4)).There have been no adverse effects to the patient reported.Patient outcome: there have been no adverse effects to the patient reported.Patient/event info - notes: request from the rep: please complete the investigation with possible causes as soon as possible since the physician wants to know the cause.Additional information: 2 prefix ziv5/ziv6/ 2-1 was the device used percutaneously? yes.2-2 which artery was the stent to be placed in? cia (ziv6:pr315914) / eia (ziv5: pr).2-3 was the approach ipsilateral or contralateral? ipsilateral; ziv6:pr315914; ziv5= left brachial approach.2-4 if contralateral, was the bifurcation angle tight? 2-5 where on the patient was the percutaneous access site? ziv5: left brachial & ziv6: right fa.2-6 details of access sheath used (name, fr size, length)? elbow: parent 6fr 88 ipsilateral:parent 6fr approximately 23cm manufactured by medikit.2-7 was the device flushed through both flushing port before the procedure, as per ifu? yes.2-8 details of the wire guide used (name, diameter, hyrdophyllic)? jupiter fc3 by boston scientific.2-9 was the patient's anatomy tortuous or calcified? tortuosity:no; calification:yes.2-10 was resistance encountered when advancing the wire guide or delivery system to the target location? no.2-11 how did the physician deal with this resistance? 2-12 was pre-dilation performed ahead of placement of the stent? yes.2-13 was post-dilation performed after the placement of the stent? yes.2-14 did the tip of the delivery system cross the target location? yes.2-15 are images of the device of procedure available? no.2-16 did the user pull the handle toward the hub during deployment and delivery system was not pushed during deployment? yes.3 prefix ziv6-ptx/zisv6-ptx: n/a.4 thrombosis: n/a.5 restenosis: n/a.6 occlusion: n/a.7 worsen claudication/pain: n/a.8 stent shortening: n/a.9 difficulty advancing over the wire guide: n/a.10 sheath separation: n/a.11 deployment difficulty.11-1 was the device flushed through the flushing port before the procedure, as per ifu? yes.11-2 was the stent fully deployed in the patient? yes.11-3 was the target site severely calcified? yes.11-4 was patient anatomy tortuous? no.11-5 was pre dilatation conducted before stent deployment? yes.11-6 was the delivery system kinked or twisted during deployment? no.

Event Description

Supplemental report being submitted due to the investigation being completed on (b)(6) 2021.

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Annex g: g07001 part/component/sub-assembly term not applicable.Device evaluation: this complaint is related to (b)(4) (¿unable to flush the device from the side arm flushing port¿) and (b)(4) (¿difficulty in stent deployment and stent elongation¿).This file investigates the difficulty encountered by the user during stent deployment of the ziv5-18-125-7-80 used during this procedure.For details of the other investigations please refer to (b)(4).The ziv5-18-125-7-80 device of lot number c1602789 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.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the (b)(6) 2021.On evaluation of the device no defects were observed on the device.The device flushed as expected.Congealed blood was flushed from the device as it was flushed in the laboratory.A 0.018¿ wire guide passed through the device with no issues.The handle was moved to the hub and no resistance was noted during the movement.Blood was observed on the inner catheter as it extended from the outer sheath as the handle moved to the hub.The red safety lock was not returned with the device.Document review: prior to distribution ziv5-18-125-7-80 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 ziv5-18-125-7-80 of lot number c1602789 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 c1602789.It should be noted that the instructions for use (ifu0043-9) states the following: ¿instructions for use.2.Introduce the extra or ultra-stiff wire guide (7.0 and 6.0 french [2.3 and 2.0 mm] systems accept 0.035 inch [0.89 mm] wire guide; 5.0 french [1.67 mm] system accepts 0.018 inch [0.46 mm] wire guide) through the access catheter across the distal segment of the target lesion.¿ there is evidence to suggest the user did not follow the ifu.The japanese packaging insert (c-ci0909i06) supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause review: a definitive root cause of the user not reading or following the ifu was identified in the laboratory.From the information available it is known that a 0.014¿ wire guide was used with this device during the procedure.As per the ifu, a 0.018¿ wire guide is required for use with this device.It is possible that the use of a non-recommended wire guide with the device caused or contributed to the difficulty encountered by the user during stent deployment.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 518 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11055746
• MDR Text Key: 255541259
• Report Number: 3001845648-2020-00982
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002437781
• UDI-Public: (01)10827002437781(17)220410(10)C1602789
• 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: 03/26/2021

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: 04/10/2022
• Device Model Number: G43778
• Device Catalogue Number: ZIV5-18-125-7-80
• Device Lot Number: C1602789
• 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: 12/04/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/04/2020; 12/04/2020
• Supplement Dates FDA Received: 02/12/2021; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1