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

Model Number G43867

Device Problem 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 11/26/2020

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

The user advanced the delivery system of the device from the left fa to the left eia during evar to place the stent from inside the distal side of the iliac leg graft to the eia.(the iliac leg graft landed in the eia.) however, the stent appeared to have been deployed and placed with deformation.Therefore, cordis's smart f10 x 80mm was additionally placed inside the deformed ziv6-35-80-10-60 stent to the distal side of the ziv6 stent.The deformation could not be resolved, but the inner lumen appeared to be patent.There have been no adverse effects to the patient reported.Related to (b)(4) (3001845648-2020-00970).This complaint was opened to capture "user error: user selects incorrect stent length" as per the image review it was confirmed that the stent was likely too short to treat/cover the diseased location despite the deformation observed.On the stent.Patient outcome: there have been no adverse effects to the patient reported.Patient/event info - notes: prefix ziv5/ziv6/.Was the device used percutaneously? (yes).Which artery was the stent to be placed in? - eia.Was the approach ipsilateral or contralateral? (ipsilateral).If contralateral, was the bifurcation angle tight? where on the patient was the percutaneous access site? femoral.Details of access sheath used (name, fr size, length)? asku.Was the device flushed through both flushing port before the procedure, as per ifu? (unknown).Details of the wire guide used (name, diameter, hyrdophyllic)? asku (b)(6) 2020) 0.035inch, aes or les).Was the patient's anatomy tortuous or calcified? (unknown).Was resistance encountered when advancing the wire guide or delivery system to the target location? (unknown).How did the physician deal with this resistance? was pre-dilation performed ahead of placement of the stent? (unknown).Was post-dilation performed after the placement of the stent? (unknown).Did the tip of the delivery system cross the target location? (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).

Manufacturer Narrative

Device evaluation note: this complaint was opened following the investigation of (b)(4) so the files are related.The ziv6-35-80-10-60 device of lot number c1760263 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 ziv6-35-80-10-60 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 ziv6-35-80-10-60 of lot number c1760263 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 c1760263.There is evidence to suggest that the user deviated from the instructions for use (ifu0043-9).Instructions for use: determine the proper stent size after complete diagnostic evaluation.The stent deployment must be performed under fluoroscopic control.Measure the length of the target lesion to determine the length of the stent required.Allow for the proximal and distal aspects of the stent to cover the entire target area.A review of the images provided suggests that although the superior end of the ziv6 was not included on the images, discounting any additional length required by tortuosity, the 60mm long ziv6 was still too short to cover the distorted segment.The lateral side of the ziv6¿s inferior end was stretched inferiorly through the segment.Although individual stent element detail is very limited, stretching of individual stent elements is suggested.The 10mm x 80mm smart stent was implanted longitudinally compressed to approximately half of its design length.Because this stent could have been deployed to its design length by just inserting it deeper, it likely was deliberately compressed with the intention of maximizing hoop strength.This suggest that some deviation from a stent¿s ifu was believed to be safe.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: the provided imaging confirms deformation of the ziv6-35-80-10-60 inferior end.The stent was likely stretched while attempting to cover a tortuous and concertinaed distal left eia segment.Root cause review: a definitive root cause of user error was determined from the information available.Images provided suggest a deviation from the instruction for use (ifu0043-9) as the 60mm long ziv6 was too short to cover the distorted segment.Summary: complaint is confirmed as the failure was verified in the image(s).A severely tortuous anatomy was observed in the imaging review.Additionally, while the superior end of the ziv6 was not included on the images, discounting any additional length required by tortuosity, the 60mm long was too short to cover the distorted segment.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

Supplemental report being submitted due to the investigation being completed on 30-apr-2021.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11238283
• MDR Text Key: 271655547
• Report Number: 3001845648-2021-00037
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002438672
• UDI-Public: (01)10827002438672(17)230921(10)C1760263
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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: 09/21/2023
• Device Model Number: G43867
• Device Catalogue Number: ZIV6-35-80-10-60
• Device Lot Number: C1760263
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1