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

Catalog Number ZIV6-80-10-4.0

Device Problems Premature Activation (1484); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.G04122 - stent.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Complaint received from distributor via e-mail on 15mar2021 (with insufficient information, listed in spanish) as reported to customer relations: zfv6-125-7-6.0 lote: c1537965 ((b)(4)), ziv6-80-10-4.0 lote: cf1764790 ((b)(4)).Additional information provided area representative on 23mar2021: "when opening the product and introduced it on the wire guide, the physician saw the stent was delivery from its sheath and the red security device was out in the plastic package, that¿s why the stent was deployed.Another stent was used without problems.Product: ziv6-80-10-4.0, lot: cf1764790, ref: g3315" additional information provided by customer on 29mar2021: "as soon as you open the product and entering it through the guide, noticed that the stent was releasing from its sheath and that the stent's lock was detatch from its plastic container,preventing its insertion, whereas its use" additional information provided by customer on 31mar2021: "how was the procedure completed? - they opened another cook stent" patient outcome: did any section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? there was no complication, the stent was deployed before the device was inserted.If yes, please describe.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.

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Annex g: g04122 - stent.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report being submitted as the description of event was updated on (b)(6)2021, additional information also received on 19-apr-2021 and added to the description of event.Complaint received from distributor via e-mail on 15mar2021 (with insufficient information, listed in spanish)--13apr2021.Additional information provided area representiative on 23mar2021: "when opening the product and introduced it on the wire guide, the physician saw the stent was delivery from its sheath and the red security device was out in the plastic package, that¿s why the stent was deployed.Another stent was used without problems.Product: ziv6-80-10-4.0, lot: cf1764790, ref: g3315" additional information provided by customer on (b)(6) 2021: "as soon as you open the product and entering it through the guide, noticed that the stent was releasing from its sheath and that the stent's lock was detatch from its plastic container,preventing its insertion, whereas its use" additional information provided by customer on (b)(6) 2021: "how was the procedure completed? - they opened another cook stent".Additional information provided by customer on (b)(6) 2021: "¿ was the product inspected for kinks or damage before entering through the fire guide? a: yes.Can you also inform us about the return status of these devices? if they have been shipped to cook, can a tracking number be provided? a: i copy isabel reyes who is in charge of sending the devices back.Patient outcome: did any section of the device remain inside the patient¿s body? no if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? there was no complication, the stent was deployed before the device was inserted.If yes, please describe.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.

Event Description

Supplemental report being submitted due to additional information received and the device evaluation.Additional information provided by customer on 19apr2021: "¿ was the product inspected for kinks or damage before entering through the fire guide? a: yes.Device evaluated 19-aug-21: "stent returned deployed but undamaged".Additional info received 24-aug-21: "the dr.Confirms that the safety was out when they opened the package".

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

Cancellation report being submitted due to completion of investigation: no adverse effect to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines 'medical device reporting for manufacturers (2016)'.

Manufacturer Narrative

Pma/510(k) # p050017 s002 and s003.Device evaluation: the ziv6-80-10-4.0 device of lot number cf1764790 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 19th august 2021.On evaluation of the device, it was noted that the stent was deployed but undamaged.The device flushed as expected and a 0.035¿ wire guide passed without issue.Following the lab evaluation, the customer was asked if the red safety lock was inadvertently removed from the device during removal from the packaging.The customer confirmed that the red safety lock was out when they opened the package.They also confirmed that the packaging was not damaged.Document review: prior to distribution ziv6-80-10-4.0 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 ziv6-80-10-4.0 of lot number cf1764790 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 cf1764790.There is no evidence to suggest the user did not follow the instructions for use (ifu0041-7).A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.The customer stated that there was no damage evident on the packaging prior to being opened but confirmed that the red safety lock was out when they opened the package.As the packaging was not damaged, the device may have been damaged inside of the packaging while being handled throughout the transport, handling and storage process.A possible root cause could be that the device may have become damaged during storage/transportation.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 as there was no patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11655647
• MDR Text Key: 280593441
• Report Number: 3001845648-2021-00305
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002331591
• UDI-Public: (01)10827002331591(17)231006(10)CF1764790
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/26/2021

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: 10/06/2023
• Device Catalogue Number: ZIV6-80-10-4.0
• Device Lot Number: CF1764790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 03/18/2021; 03/18/2021; 03/18/2021
• Supplement Dates FDA Received: 05/11/2021; 09/17/2021; 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1