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

Model Number G38490

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # : p100022/s014.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations, "when they deployed it, the stent stretched out to about 200mm in length instead of 120mm.They placed another stent over the device." updated complaint information from the dm: "when deploying stent, the first 40mm deployed normally, then a wire popped out where the thumbwheel is.He had to crank really hard at that point and the stent started to elongate.He ended up leaving the stent as it was.There was not an additional stent placed" -(b)(4) 05sept2018.

Manufacturer Narrative

Pma/510(k) # : p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Device evaluation the zisv6-35-125-7-120-ptx device of lot number c1518918 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 27 september 2018.The returned device lab examination findings and observations can be referred through attached photos.Complaint is confirmed as the failure was verified in the laboratory.The retraction wire was separated from the stent retraction sheath (srs) and some of the wire was protruding through the thumbwheel.Difficult patient anatomy is a possible root cause for this complaint.Difficult patient anatomy could have caused or contributed to resistance during deployment.It is possible that this resistance contributed to high deployment forces causing the retraction wire to separate from the srs as the stent was deploying.It is known that the physician used force to turn the thumbwheel to complete stent deployment after the wire popped out.It is possible that the stent was not fully out of the delivery system when the physician removed the delivery system from the patient¿s body and as the physician pulled the device proximally, the stent stretched.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.It can be noted that the instructions for use states the following: ¿do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.¿ it may be noted that a capa ((b)(4)) has been initiated to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.Document review the zisv6-35-125-7-120-ptx device of lot number c1518918 contains zvsp6-t-35-125-7-120-is (zilver ptx) of lot numbers ch1466608 and ch1507881.Prior to distribution all zisv6 devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records (c1518918, ch1466608 and ch1507881) revealed no discrepancies that could have contributed to this complaint.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 c1518918.Summary complaint is confirmed as the failure was verified in the laboratory.The retraction wire was separated from the stent retraction sheath (srs) and some of the wire was protruding through the thumbwheel.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

As reported to customer relations, "when they deployed it, the stent stretched out to about 200mm in length instead of 120mm.They placed another stent over the device." updated complaint information: "when deploying stent, the first 40mm deployed normally, then a wire popped out where the thumbwheel is.He had to crank really hard at that point and the stent started to elongate.He ended up leaving the stent as it was.There was not an additional stent placed" -(b)(6) 2018.

• 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
• MDR Report Key: 7925218
• MDR Text Key: 125152760
• Report Number: 3001845648-2018-00462
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384900
• UDI-Public: (01)10827002384900(17)200327(10)C1518918
• 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
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2020
• Device Model Number: G38490
• Device Catalogue Number: ZISV6-35-125-7-120-PTX
• Device Lot Number: C1518918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates FDA Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 107