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

Catalog Number ZISV6-35-125-5.0-120-PTX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # : p100022/s014.(b)(4).(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Report is being submitted as it has been assessed as moderate risk.Defect complaint, de-sterilisation, no more information.No more details reported, awaiting for confirmation if the device is going to be returned and if it was in contact with the patient.Defect complaint, de-sterilisation, no more information.No more information, customer was contacted by tef at 14.50, mr.Meloux is not there for more details.Package is on a box with the other products and it was damaged on the stock the customer ask just to exchange when we send the products it was ok and no problem it was during the stock age.

Event Description

Defect complaint, de-sterilisation, no more information.No more details reported, awaiting for confirmation if the device is going to be returned and if it was in contact with the patient as per complaint form: defect complaint, de-sterilisation, no more information.No more information, customer was contacted by tef at 14.50, mr.(b)(4) is not there for more details.This is just in fact the package is on a box with the other products and it was damaged on the stock the customer ask just to exchange when we send the products it was ok and no problem it was during the stock age.

Manufacturer Narrative

510 (k) number: n/a.(b)(4).Exemption number: e2016031.Information pertaining to as follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Cancellation report is being submitted.It has been confirmed that the initial reason for reporting (sterility) does not apply.Complaint is not confirmed as the failure could not be verified in the laboratory.Device evaluation there are two devices related to this complaint.For details of the second investigation refer to (b)(4).The zisv6-35-125-6.0-120-ptx device of lot number c1442875 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.The customer was contacted on several occasions to provide additional information in relation to this complaint.However no response was received.The investigation will be updated should any information be made available to cook ireland in the future.The device related to this occurrence underwent a laboratory evaluation on the 23 july 2018.On evaluation of the returned device, crinkles were noted on the distal stent retraction sheath (srs).Crinkles are often noticed on returned devices that have been used in difficult patient anatomy.The crinkles on this device suggest the device was used and the patient¿s anatomy was possibly difficult.The red safety trigger was depressed and the stent was not returned with the device (ref att.'images').It may be noted that the original complaint information stated there was a sterility issue and that the box was damaged.The customer was asked to confirm if there was a sterility issue with the device, the response received was ¿no sterility issues¿.When asked to confirm what was meant by ¿damaged on the stock¿ the customer confirmed this should have read ¿damaged on the dock.¿ when asked to confirm what the ¿dock¿ referred to and to confirm what the damage was, the customer responded ¿loading dock where the trucks unload the goods at the hospital¿ and ¿the complaint external packaging was damaged (crushed)¿.The shipping box was not returned with the complaint devices to cirl therefore the damage to the external packaging cannot be assessed.The complaint devices were returned with the original marketing boxes on which no damage was observed.Based on the findings observed in the laboratory it was clear that the device had been used during the procedure.It may be noted that the original file and returned complaint form contained contradictory information.It should be noted that the shipping box displayed in the images contains two complaint (pr) numbers one of which contains a typographical error.The pr number ¿(b)(4)¿ on the shipping box should read ¿(b)(4)¿.Both of the returned devices are related.Complaint is not confirmed as the failure could not be verified in the laboratory.Based on the information available to date, there is no evidence to suggest there were any issues with this device.As previously stated the customer confirmed there were no sterility issues and the marketing boxes returned with the devices were not damaged.The lab evaluation suggests the device was used.No issues were reported regarding the use of the device or its functionality during or after the procedure.As we have not received a response to the requested additional information and as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0117-2).Document review: the zisv6-35-125-6.0-120-ptx device of lot number c1442875 contains zvsp6-t-35-125-6.0-120-is (zilver ptx) of qc numbers (b)(4).Prior to distribution all zisv6 devices are subject to visual inspection and functional checks to ensure device integrity as per (b)(4).A review of the relevant manufacturing records (c1442875, (b)(4)) revealed no discrepancies that could have contributed to this complaint.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1442875.Summary: complaint is not confirmed as the failure could not be 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

Defect complaint, de-sterilisation, no more information.No more details reported, awaiting for confirmation if the device is going to be returned and if it was in contact with the patient.As per complaint form: defect complaint, de-sterilisation, no more information.No more information, customer was contacted by tef at 14.50, mr.(b)(6) is not there for more details.This is just in fact the package is on a box with the other products and it was damaged on the stock the customer ask just to exchange when we send the products it was ok and no problem it was during the stock age.

Manufacturer Narrative

510 (k) number: n/a.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

510(k) number: na.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).(b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Defect complaint, de-sterilisation, no more information.No more details reported, awaiting for confirmation if the device is going to be returned and if it was in contact with the patient.As per complaint form: defect complaint, de-sterilisation, no more information.No more information, customer was contacted by tef at 14.50, mr.Meloux is not there for more details.This is just in fact the package is on a box with the other products and it was damaged on the stock the customer ask just to exchange when we send the products it was ok and no problem it was during the stock age.

• 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
• MDR Report Key: 7741767
• MDR Text Key: 115777263
• Report Number: 3001845648-2018-00358
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352855
• UDI-Public: (01)10827002352855(17)191115(10)C1442875
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2019
• Device Catalogue Number: ZISV6-35-125-5.0-120-PTX
• Device Lot Number: C1442875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/02/2018
• Event Location: Hospital
• Date Manufacturer Received: 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1