MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number G38491

Device Problems Difficult to Remove (1528); Difficult or Delayed Activation (2577)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

"the deployment system, after the stent was deployed, would not come off the wire.The user advanced the deployment system beyond the stent, were able to then remove the wire, but were not able to reinsert a wire into the lumen of the device (wouldn't even get past the handle).At that point, dm recommended cutting the handle away with shears and trying to reinsert the wire into the lumen of the deployment device.User was unable to advance the wire after shearing, user removed remainder of deployment system from patient, and continued by recrossing the stents to complete the procedure.(b)(4).

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report being submitted due to lab evaluation complete on 14-oct-2021 lab evaluation completed on 14-oct-21: inner catheter inside handle kinked.

Manufacturer Narrative

Device evaluation: 1 unit of zisv6-35-125-7-140-ptx and lot# c1838260 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 14 oct 2021.On evaluation of the device it was observed that there was a kink on the inner catheter inside the handle.Device was flushed as delivery system was cut on return.Documents review including ifu review: prior to distribution zisv6-35-125-7-140-ptx 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 zisv6-35-125-7-140-ptx of lot number c1838260 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 c1838260.It should be noted that the instructions for use (ifu0118) states the following: ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ 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 brake/safety lock failure.As per engineering input "the whole issue may have arisen from the difficulty in pressing the red safety button.It doesn¿t look like it in the images but the extra effort to press it (and i don¿t know the reason, maybe the red part itself was defective or not sitting properly in the handle) could have damaged the blue tubing near it, effectively clamping the wire guide inside the inner catheter and making it difficult to remove the delivery system from the wire guide.The push forward to try to get them to release probably worked but kinked the inner catheter.It was then possible to withdraw the system off the first wire guide (despite the kink) but not possible to advance over a second wire guide".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.

Event Description

Supplemental report being submitted due to completion of investigation on 28-apr-2022.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• 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: 12347344
• MDR Text Key: 267429822
• Report Number: 3001845648-2021-00617
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384917
• UDI-Public: (01)10827002384917(17)230421(10)C1838260
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2023
• Device Model Number: G38491
• Device Catalogue Number: ZISV6-35-125-7-140-PTX
• Device Lot Number: C1838260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/22/2021
• Event Location: Hospital
• Date Manufacturer Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1