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

Catalog Number ZISV6-35-125-6-120-PTX

Device Problems Break (1069); Detachment Of Device Component (1104); Appropriate Term/Code Not Available (3191)

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

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p100022/s014.(b)(4).The zisv6-35-125-6-120-ptx device of lot c1258839 has not yet been returned.With the information provided, a document based investigation was carried out.The investigation will be updated once the device has been returned and evaluated.From customer testimony, it is known that the patient anatomy was calcified, but not tortuous.There was no resistance encountered during advancement or deployment.There was no damage to the wire guide observed.The lesion was crossed with a terumo glide wire, which was switched for a amplatz wire guide prior to advancing the complaint device.The amplatz wire guide was washed with saline while still in the packaging, and was placed through the catheter and then wiped when removed from the catheter.The complaint device was flushed as per the ifu.The target location was in the superficial femoral artery (sfa).There is no evidence to suggest that this incident did not occur.Therefore, the customer complaint is confirmed based on customer testimony.As the device has not yet been returned for evaluation, 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

The stent was placed in the patient without incident.When they were pulling the delivery catheter out of the sheath, they noticed that the inner catheter of the delivery system became separated from the rest of the delivery system.At that point, they pulled the wire and the inner portion out together and continued on with the case without further incidents or complications.It was the physician's and tech's impression that the inner catheter had been stuck on the amplatz (unknown manufacturer/part#) wire which caused the separation while pulling out the delivery system.

Manufacturer Narrative

Pma/510(k) # p100022/s014.(b)(4).This follow up report is being submitted to cancel the initial report.Based on the device evaluation it was confirmed that the distal inner separated from the flla component and no device / catheter breakage occurred.This event has been re-assessed as no longer meeting the reporting criteria of an fda mdr malfunction report.The zisv6-35-125-6-120-ptx device of lot c1258839 was returned with the open, original packaging.With the information provided, a physical examination and document based investigation was conducted.From customer testimony, it is known that the patient anatomy was calcified, but not tortuous.There was no resistance encountered during advancement or deployment.There was no damage to the wire guide observed.The lesion was crossed with a terumo glide wire, which was switched for an amplatz wire guide prior to advancing the complaint device.The amplatz wire guide was washed with saline while still in the packaging, and was placed through the catheter and then wiped when removed from the catheter.The complaint device was flushed as per the ifu.The target location was in the superficial femoral artery (sfa).Additional information was provided by the customer.The procedure duration was 45 to 60 minutes before the inner catheter separated.The physician felt resistance but did not use excessive force to withdraw the device.On evaluation of the returned device, it was observed that the wire guide was still loaded into the device on return.The wire guide was measured as 0.035" in diameter.The handle was opened and the distal inner was observed to be separated from the flushing port (flla) component.It was noted that there was glue residue present.The 0.035" diameter wire guide could freely pass through the flla component.The wire was still inside the distal inner component on device return, and was removed with difficulty from the device by the engineers.A kink was observed on the wire guide, at 162 cm from the distal end.A new 0.035" diameter wire guide was passed through the distal inner component, with no issues reported.There was no evidence that the device was manufactured incorrectly.The customer complaint is confirmed as the distal inner component was observed to be separated inside the device handle.Possible causes for this occurrence could include the kink on the wire guide.This could have caused resistance during withdrawal, causing or contributing to the distal inner separating from the flla component.However, 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 to cancel the initial report.Based on the device evaluation it was confirmed that no device / catheter breakage occurred.No adverse effects to the patient were reported.This event has been re-assessed as no longer meeting the reporting criteria of an fda mdr malfunction report.Initial report details; the stent was placed in the patient without incident.When they were pulling the delivery catheter out of the sheath, they noticed that the inner catheter of the delivery system became separated from the rest of the delivery system.At that point, they pulled the wire and the inner portion out together and continued on with the case without further incidents or complications.It was the physician's and tech's impression that the inner catheter had been stuck on the amplatz (unknown manufacturer/part#) wire which caused the separation while pulling out the delivery system.

• 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: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6345089
• MDR Text Key: 68088640
• Report Number: 3001845648-2017-00055
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)170629(10)C1258839
• 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
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6-120-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: 02/20/2017
• Event Location: Hospital
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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
• Patient Age: 76 YR