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

Catalog Number ZISV6-35-125-6.0-100-PTX

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

After the stent was deployed (safely), the stent system was stuck and could not be walked off the wire.The system was completely stuck and we had to remove the wire and stent as a whole no unintended part of the device remained inside the patient's body.No additional procedure was required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.(b)(4) -several attempts made to customer (b)(6) 2023.Manager response manager response-(b)(4) attempt to contact the clinical and his team three times via email and she has also called them.Lbe01 (b)(6) 2023.(b)(4) - request for additional information #3 (b)(6) 2023.(b)(4) - request for additional information # 2 (b)(6) 2023.

Manufacturer Narrative

Pma 510k #p100022/s014.Device evaluation: the zisv6-35-125-6.0-100-ptx device of lot number c2045253 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.The device related to this occurrence underwent a laboratory evaluation on the 12th sept 2023.On evaluation of the device, the following was noted: visual inspection.Wire guide not returned.Stent not returned.Red safety button depressed on return.Sheath examined and compression felt 25cm below the strain relief.Functional inspection: device flushed with no issue.0.035 wire guide measured and fed through the device without issue.This is the correct wire guide for this device.Manufacturing records: prior to distribution all zilver ptx devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Ifu/label review: the instructions for use (ifu0117) states the following: ¿a 0.89mm (0.035 inch) wire guide should be used during tracking, deployment and removal in order to ensure adequate support of the system.If hydrophilic wire guides are used they must be kept fully activated.¿ ¿following stent deployment, if resistance is met during the withdrawal of the delivery system, carefully remove the delivery system and wire guide as a unit.If resistance is still encountered during removal of the delivery system and wire guide as a unit, remove the wire guide, delivery system and introducer sheath together as a unit.¿ there is no evidence to suggest the user did not follow the ifu.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined.A possible root cause could be attributed to congealed blood in the delivery system and/or a difficult patient anatomy.It is possible that congealed blood bound the wire guide and the outer sheath preventing removal of the device over the wire guide resulting in the wire guide and the delivery system being removed together.As the delivery system was returned without the wire guide, this cannot be verified.The user may have removed the wire guide, when it was removed as a whole from the patient, dislodging the congealed blood, as in the lab evaluation, the device flushed with no issue and a wire guide fed through the device with no issue.Compression seen on the outer sheath during the lab evaluation could indicate a difficult patient anatomy which could have compressed the outer sheath resulting in the delivery system becoming difficult to remove.Numerous attempts were made to obtain more information regarding the patients anatomy, the procedure itself and the outcome regarding how the procedure was completed.The original reporter is no longer in employment with cook and no more information is available.Should more information become available at a later stage, the file can be updated accordingly.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Summary: according to the initial reporter, after the stent was deployed (safely), the stent system was stuck and could not be walked off the wire.The system was completely stuck, and they had to remove the wire and stent as a whole.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude a definitive root cause was not established.Possible root causes include congealed blood in the delivery system and/or a difficult patient anatomy compressing the outer sheath.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplement report being submitted due to the completion of the investigation on 13-oct-2023.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 17815627
• MDR Text Key: 324226129
• Report Number: 3001845648-2023-00733
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352848
• UDI-Public: (01)10827002352848(17)250120(10)C2045253
• Combination Product (y/n): Y
• 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
• Report Date: 10/13/2023

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 Catalogue Number: ZISV6-35-125-6.0-100-PTX
• Device Lot Number: C2045253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/25/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• 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