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

Catalog Number ZISV6-35-80-6.0-60-PTX

Device Problem Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Device evaluation: it is known that the zisv6-35-80-6.0-60-ptx device was the device involved in this complaint.At the time of the investigation the device packaging was not available for evaluation, therefore a document based investigation was carried out.An update on the status of the packaging has been requested.Following the returned of the packaging the investigation will be updated.Additional information has received from the customer stated that no part of the device became non sterile as a result of this issue.In the complaint description the customer referred to a black plastic bag, this was queried and it was determined that the customer was in fact referring to the white foil pouch which is the outer packaging.It was stated that there was no issue with the product itself, no patients were involved, no results for the application were feared and no moment of danger neither for the patient nor the user.The complaint/negative feedback was confirmed based on customer testimony.This complaint is deemed the opinion of the user and no manufacturing or functional defect was reported.Document review: prior to distribution, all zisv6 (zilver ptx) devices are subject to visual inspection of packaging integrity a review of the relevant manufacturing records did not reveal any discrepancies which could have contributed to this complaint issue.Summary: the complaint/negative feedback was confirmed based on customer testimony.This complaint is deemed the opinion of the user and no manufacturing or functional defect was reported.No adverse events were reported as a result of this occurrence as no patient contact was made.This was negative feedback from the user.Complaints/negative feedback of this nature will continue to be monitored for any potential emerging trends.

Event Description

Rep collected feedback from customer that the packaging from our ptx stents in general is not great.The outer black plastic bag has a pull open line but its hart to open without damaging the sterile bag in it too -with the product itself- nothing wrong- "as per complaint form": the customer complains about the stiff cardboard with which he scratches his hands, and the outer foil bags of the zptx stent, where a: the stent has to be shaken downwards because it lies exactly on the level of the pre-perforated removal aid and b: despite the help of tearing, the outer protective bags cannot be torn nicely diagonally.There is a risk that the inner package will also be torn, causing the stent to become non-sterile.No patients are involved here, no results for the application are to be feared, no moment of danger neither for the patient nor the user.A pure complaint to the packaging from the point of view of the user.As we were told by our pm's to send in kind of a complaint to collect market feedback.I do have 3 of these pouches with me and will send them in as examples for a better understanding.This market feedback is not new - it is heard everywhere where we sell the zptx.

Manufacturer Narrative

Pma/510(k) # p100022/s014.Cook (b)(4) (manufacturer) is submitting this report on behalf of (b)(4).Exemption number: e2016031.(b)(4).A follow-up mdr is being submitted to include the device evaluation details.This investigation deals with zisv6-35-80-6.0-60-ptx device of lot number c1382132.For details of the other investigation reference the above complaint files.The zisv6-35-80-6.0-60-ptx device of lot number c1382132 device packaging involved in this complaint was returned for evaluation, and was open on receipt.With the information provided, a physical examination and document based investigation was conducted.On evaluation of the returned device packaging, it was noted that the packaging was returned without the device.The outer foil was returned, with a portion of the inner tyvek.Additional information has been received from the customer stated that no part of the device became non sterile as a result of this issue.In the complaint description the customer referred to a black plastic bag, this was queried and it was determined that the customer was in fact referring to the white foil pouch which is the outer packaging.It was stated that there was no issue with the product itself, no patients were involved, no results for the application were feared and no moment of danger neither for the patient nor the user.Further confirmation was requested of the customer, to ask if the inner tyvek was torn with the outer pouch.The investigation will be updated once the information has been provided.The complaint/negative feedback was confirmed based on customer testimony.This complaint is deemed the opinion of the user and no manufacturing or functional defect was reported.Prior to distribution, all zisv6 (zilver ptx) devices are subject to visual inspection of packaging integrity.A review of the relevant manufacturing records (c1382132, ch1362316) did not reveal any discrepancies which could have contributed to this complaint issue.Upon review of complaints, no further negative feedback was reported previously for this lot number.(ref.Att.Occurrence report).Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1382132.No adverse events were reported as a result of this occurrence as no patient contact was made.This was negative feedback from the user.Complaints/negative feedback of this nature will continue to be monitored for any potential emerging trends.

Event Description

A follow-up mdr is being submitted to include the device evaluation details.Initial report details: rep collected feedback from customer that the packaging from our ptx stents in general is not great.The outer black plastic bag has a pull open line but its hart to open without damaging the sterile bag in it too -with the product itself- nothing wrong- "as per complaint form": the customer complains about the stiff cardboard with which he scratches his hands, and the outer foil bags of the zptx stent, where a: the stent has to be shaken downwards because it lies exactly on the level of the pre-perforated removal aid and b: despite the help of tearing, the outer protective bags cannot be torn nicely diagonally.There is a risk that the inner package will also be torn, causing the stent to become non-sterile.No patients are involved here, no results for the application are to be feared, no moment of danger neither for the patient nor the user.A pure complaint to the packaging from the point of view of the user.As we were told by our pm's to send in kind of a complaint to collect market feedback.I do have 3 of these pouches with me and will send them in as examples for a better understanding.This market feedback is not new - it is heard everywhere where we sell the zptx.

• 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 Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6910700
• MDR Text Key: 89593790
• Report Number: 3001845648-2017-00424
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002353081
• UDI-Public: (01)10827002353081(17)190602(10)C1382132
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-80-6.0-60-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• 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