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

Model Number G38482

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s014.The zisv6-35-125-6-120-ptx device of lot number c1328016 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The sales representative has confirmed that the device was shipped.The investigation will be updated once the device has been returned and evaluated.There is no evidence to suggest that this incident did not occur.Therefore, the customer complaint is confirmed based on customer testimony.Possible causes for this occurrence could include the handling of the device as the device packaging was opened, with the customer not moving the inner packaging away from the tear notches of the foil pouch.However, as the complaint device was not returned for evaluation and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.From the product instructions for use: "do not use the product if there is doubt as to whether the product is sterile." prior to distribution, all zisv6 (zilver ptx thumbwheel) devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records did not reveal any discrepancies which could have contributed to this complaint issue.Upon review of complaints, this failure mode has not occurred previously with this 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 c1328016.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The incident occurred as the device packaging was opened, prior to patient contact.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

The physician went to use this stent.The inner packaging was sealed but when they opened it to get the stent, the packaging the stent was in was already torn.

Manufacturer Narrative

(b)(4).Exemption number: e2016031 importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) # p100022/s014.This follow up report is being submitted to inform fda that the device has been received and a lab evaluation is pending.A follow up mdr will be submitted within 30 days with the final investigation conclusions.Initial investigation details: the zisv6-35-125-6-120-ptx device of lot number c1328016 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The sales representative has confirmed that the device was shipped.The investigation will be updated once the device has been returned and evaluated.There is no evidence to suggest that this incident did not occur.Therefore, the customer complaint is confirmed based on customer testimony.Possible causes for this occurrence could include the handling of the device as the device packaging was opened, with the customer not moving the inner packaging away from the tear notches of the foil pouch.However, as the complaint device was not returned for evaluation and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.From the product instructions for use: "do not use the product if there is doubt as to whether the product is sterile." prior to distribution, all zisv6 (zilver ptx thumbwheel) devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records did not reveal any discrepancies which could have contributed to this complaint issue.Upon review of complaints, this failure mode has not occurred previously with this 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 c1328016.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The incident occurred as the device packaging was opened, prior to patient contact.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up report is being submitted to inform fda that the device has been received and a lab evaluation is pending.A follow up mdr will be submitted within 30 days with the final investigation conclusions.Initial report details: the physician went to use this stent.The inner packaging was sealed but when they opened it to get the stent, the packaging the stent was in was already torn.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Exemption number: e2016031.(b)(4).Pma/510(k) # p100022/s014.This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.The zisv6-35-125-6-120-ptx device of lot number c1328016 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.On evaluation of the returned device, it was observed that the device was returned with both the inner tyvek and the outer foil pouches.A tear was seen in the tyvek pouch, at a location corresponding to the opening tear in the foil pouch.Complaint is confirmed as the failure was verified in the laboratory, as the inner tyvek was observed to be torn in the location corresponding to foil pouch notch.Possible causes for this occurrence could include the handling of the device as the device packaging was opened, with the customer not moving the inner packaging away from the tear notches of the foil pouch.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.From the product instructions for use : "do not use the product if there is doubt as to whether the product is sterile." prior to distribution, all zisv6 (zilver ptx thumbwheel) devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records did not reveal any discrepancies which could have contributed to this complaint issue.Upon review of complaints, this failure mode has not occurred previously with this 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 c1328016.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The incident occurred as the device packaging was opened, prior to patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.Initial report details: the physician went to use this stent.The inner packaging was sealed but when they opened it to get the stent, the packaging the stent was in was already torn.

• 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 Contact: michael galvin ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6829798
• MDR Text Key: 84095460
• Report Number: 3001845648-2017-00368
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)171013(10)C1328016
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/02/2017
• Event Location: Hospital
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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