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

Model Number	G43783
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
"some portion of the delivery system broke off into the patient.When it broke off, the doctor felt comfortable that the patient "would be fine" and didn't attempt retrieval during the procedure." lab evaluation completed on 26-nov-2020, the following observations were noted: device could not be flushed.0.018 inch wire guide advanced through device with resistance.Could not advance wire guide beyond approx.107cm.Handle moved to hub with a lot of resistance.Inner catheter protrudes through the sheath at approx.2.5cm from distal end of sheath when handle was moved to hub.Patient outcome: did any unintended section of the device remain inside the patient¿s body? yes.If yes, please describe.See event description.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? if yes, please describe.Did the patient require any additional procedures due to this occurrence? if yes, please describe.Did the product cause or contribute to the need for additional procedures? if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Additional questions; 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: did the patient have any risk factors for thrombosis, restenosis, or occlusion? what other medications and/or treatments was the patient receiving? if occlusion occurred, can it be confirmed if the occlusion is related to thrombosis or restenosis? if the event involved claudication / pain, request the following: is the reported event a symptom of restenosis or thrombosis? if no restenosis or thrombosis occurred how it was determined that the zilver stents caused / contributed to the event? if the event involves stent shortening, request the following: was there any evidence of post deployment stent compression or deformation? was the delivery system able to be advanced to the target site easily / with no resistance? was the handle pulled toward the hub while the delivery system remained stationary during deployment? if the event involves sheath separation, request the following: was there high resistance encountered during any part of the procedure, wire guide advancement, stent deployment, etc.? was pre-dilatation conducted prior to stent deployment? was the handle puled toward the hub while the delivery system remained stationary during deployment? if the event involving deployment difficulties, request the following: was the stent eventually deployed? was pre-dilatation conducted before stent deployment? was the handle pulled toward the hub while the delivery system remained stationary during deployment? if the event that involve device stuck on wire guide, difficult to advance / remove delivery system and/or wire guide, request the following: was the wire guide hydrophilic or non-hydrophilic? how long was the procedure from advancing delivery system to the moment when the user attempted to remove the device? was the wire guide new or was the wire guide used previously before advancing the zilver delivery system? if used, was the wire guide wiped between uses?.
Additional Manufacturer Narrative
Pma# - p050017/s002 and s003.Device evaluation: the ziv5-18-125-8-80 device of lot number c1757307 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 26th november 2020.On evaluation of the device, it was found that the distal white tip on the distal end of the outer sheath is missing.A kink and perforation were observed approx.2.5cm from distal end of the sheath.The device could not be flushed.A 0.018-inch wire guide advanced through the device with resistance.The wire guide could not be advanced beyond approx.107cm.The handle moved to the hub with a lot of resistance.The inner catheter protrudes through the sheath at approx.2.5cm from distal end of sheath when handle was moved to hub.Document review: prior to distribution ziv5-18-125-8-80 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 ziv5-18-125-8-80 of lot number c1757307 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 c1757307.It should be noted that the instructions for use are ifu0043-9.There is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to difficult patient anatomy or handling of the device during device prep.When the device was evaluated in the laboratory on the 26th november 2020, high resistance was felt when moving the handle to the hub.This could be due to high degree of vessel tortuosity and calcification in patient causing kinks and perforation, thus leading to resistance in handle.Summary: complaint is confirmed as the failure was verified in the laboratory.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
• Common Device Name: 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12802071
• Report Number: 3001845648-2021-00803
• Device Sequence Number: 4757385
• Product Code: NIO
• UDI-Device Identifier: 10827002437835
• UDI-Public: (01)10827002437835(17)230910(10)C1757307
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2023
• Device Model Number: G43783
• Device Catalogue Number: ZIV5-18-125-8-80
• Device Lot Number: C1757307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/22/2020
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown