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

Catalog Number ZISV6-35-125-6.0-80-PTX

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p100022/s014.This event is currently under investigation.A follow up report will be submitted with the device evaluation and investigation conclusions.

Event Description

It was reported that the applicator could not be retrieved in one piece and separated in two parts.The heavily calcified vessel (no tortuous) was predilated.The stent properly rinsed.The stent could be introduced without problems (no increased friction) through the introducer and placed in the right place.Even when the stent system was removed, nothing unusual occurred.But the system was divided in two parts.The second part came out somehow with some distance.Nothing happened to the patient.

Manufacturer Narrative

Pma/510(k) #: p100022/s014.The zisv6-35-125-6.0-80-ptx device of lot c1208445 was returned, without the original packaging.With the information provided, a physical examination and document based investigation was carried out.From customer testimony, it is known that the patient anatomy was calcified, but not tortuous.There was no resistance encountered during advancement or deployment.The wire guide was in place throughout the procedure.There are no images of the procedure available.The patient bifurcation was not at a tight angle.The heavily calcified vessel (not tortuous) was pre-dilated.The stent was properly flushed before use.The stent could be introduced without problems (no increased friction) through the introducer and placed in the right place.Even when the stent system was removed, nothing unusual occurred.But the system was divided in two parts.There were no adverse effects to the patient.No additional procedures were required to remove the detached portion of the device.On evaluation of the returned device, a kink was observed in the stent retraction sheath, 28 mm proximally from the proximal end of the stent stop.The kinking could have occurred due to the patient anatomy.The proximal and distal inner components were broken.The customer complaint can be confirmed as the distal and proximal inners were broken.Product development engineers were unable to determine a possible root cause.With the information provided, and as the conditions of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.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 this lot number.According to information provided, the patient did not experience any adverse effects due to this occurrence.Quality engineering will continue to monitor complaints of this nature 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 complaint details: it was reported that the applicator could not be retrieved in one piece and separated in two parts.The heavily calcified vessel (no tortuous) was predilated.The stent properly rinsed.The stent could be introduced without problems (no increased friction) through the introducer and placed in the right place.Even when the stent system was removed, nothing unusual occurred.But the system was divided in two parts.The second part came out somehow with some distance.Nothing happened to the patient.

• 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: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6275690
• MDR Text Key: 65709703
• Report Number: 3001845648-2017-00024
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352831
• UDI-Public: (01)10827002352831(17)171222(10)C1208445
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6.0-80-PTX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2016
• Event Location: Hospital
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2016
• 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