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

Model Number G38487

Device Problems Break (1069); Material Deformation (2976); Activation Failure (3270)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

As initially reported to customer relations: a patient of unspecified gender and age underwent an unspecified procedure in which the zilver ptx stent was used.The ptx stent didn't deploy correctly.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the receipt of additional information.Date of event, lot number, patient demographics, details of procedure and patient outcome provided additional information per customers reply received with returned product.Th 02nov2022.Stent involuted during deployment.Another stent was placed.1.Did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization? no 3.Did the patient require any additional procedures due to this occurrence? no if yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no if yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no.6.Has the complainant reported that the product caused or contributed to the adverse effects? non.Please specify adverse effects and provide details.

Event Description

Supplemental report is being submitted due to the device returned and lab evaluation.Lab evaluation date: 22 sept 2022.Visual inspection: red safety lock depressed on return.Stent not returned with device.Functional inspection: device flushes with no issue.Wire guide passes through with no issue.0.035 inch.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to completion of the lab re evaluation on the (b)(6) 2022.

Manufacturer Narrative

Device evaluation: the zisv6-35-125-7-60-ptx device of lot number c1950344 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 22 sept 2022.On evaluation of the device the following was noted: visual inspection - red safety lock depressed on return and the stent not returned with device.Functional inspection: device flushes with no issue.Wire guide passes through with no issue.0.035 inch.On request from engineering the device was further evaluated on the 29th november 2022.Upon functional inspection, the thumbwheel rotated freely.The handle was opened and the retraction wire was observed to be separated from the stent retraction sheath (srs).Document review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records 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 for this work order.It should be noted that the instructions for use states the following: ''do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.'¿ 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.It is possibly that difficult patient anatomy caused resistance when the user rotated the device thumbwheel causing the stent to deform on deployment.As per engineering input ¿a tight arch caused resistance and made it harder to withdraw the srs to deploy the stent.This resistance/higher force to deploy lead to a snap when the thumbwheel was turned.This was most likely the retraction wire separating from the sheath, leaving the stent only partially deployed.The delivery system may have moved in attempting to get the stent out (compressing the stent out of shape) or stretching it when the delivery system was being pulled out.¿ summary: complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated 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 is being submitted due to the completion of the investigation on 31-jan-2023.

• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 15409488
• MDR Text Key: 299769523
• Report Number: 3001845648-2022-00628
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384870
• UDI-Public: (01)10827002384870(17)240426(10)C1950344
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38487
• Device Catalogue Number: ZISV6-35-125-7-60-PTX
• Device Lot Number: C1950344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/16/2022
• Event Location: Hospital
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 108 KG