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

Catalog Number ZIV6-35-80-6.0-80-PTX

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problems Surgical procedure, additional (2564); Device Embedded In Tissue or Plaque (3165)

Event Date 08/11/2014

Event Type  Injury  

Event Description

The complaint details are summarized as follows: a zilver ptx was used to stent the origin of the sfa but kept moving back proximally during deployment.The stent did not deploy precisely, despite holding the delivery system straight, the stent kept deploying more proximally.It was only possible for the stent to be deployed 2cm but then it was not possible to recover the stent to move/re-sheath.It was then decided to remove the stent through a 6fr sheath.The stent was deployed in the sheath.The user removed the sheath to take the stent out.2-3 cm distal stent deployed and could not be re-sheathed.The stent was removed in pieces with forceps.A small amount of the stent remained behind.The patient will have a femoral-popliteal bypass surgery to remove the remaining piece of the stent.Numerous requests have been made to the user to clarify and expand upon the complaint details (including patient outcome details).However, to date a response has not been received.

Manufacturer Narrative

Unique device identifier from product lot# (b)(4).One x (b)(4) device of lot number c1009243 was returned for evaluation.Device was not returned in the original package.On evaluation of the returned device it was evident that the stent was returned separately and was damaged.A few broken stent pieces were returned separately together with the stent confirming stent fracture.Further visual examination of the returned stent revealed missing gold rivets indicating that distal part of the stent was missing.Using calibrated ruler, the returned stent measured approx.5.5cm-6.0cm, indicating that approx.2.0cm-2.5cm of stent was missing.Complaint information as well as additional information provided by the sales rep indicates that a small portion of the stent remained in the patient and will be removed during femoral-popliteal bypass surgery.Using calibrated ruler the outer sheath measured and was noted to be within specification.The entire delivery system has been examined for damage and no tactile damage could be detected.The device's handle could be advanced/retracted without resistance.Distal part of the tip was visually examined and no damage to the tip was evident.Using 1ml syringe with water the device was flushed through the handle port and through the side port without difficulties.The device was advanced over the non hydrophilic 0.035" wire guide with no issues.No damage or indentation was evident on the edge of the pusher ring.No excess glue was observed proximally to the pusher ring.From the examination of the returned device there is no evidence to suggest that the device has malfunctioned or was manufactured incorrectly.It may be noted that the following additional information was provided by the sales rep: the user pulled the handle 2-3cm before the user attempted tore-sheath the stent, physician said the device kept jumping back, proximally, which he couldn't have as he wanted to maintain the opening to the profunda.The patient had to go for a femoral-popliteal bypass.The device was retrieved using forceps and because of this there is a small part of the stent still in the soft tissue.No other information was available at the time of complaint investigation.Although requested images, x-rays or scans relating to this incident have not been provided.Upon evaluation of the returned device, the customer complaint can be confirmed as the stent was not deployed during the procedure and the distal part of the stent was found to be fractured and missing.A possible cause of the stent fracture in this occurrence may be attributed to the user technique during the procedure.Available information indicates that the user attempted to retract a partially deployed stent, which is not possible due to stent expansion.As indicated in the zilver ptx instruction for use, zilver ptx stent is not designed for repositioning or recapturing.As a result, the partially deployed stent had fractured and was removed in pieces using the forceps.The root cause of stent fracture in this case may be attributed to stent deployment difficulty.Available information indicates that the user could not precisely deploy the stent as the "device kept jumping back, proximally".Incorrect device handling during deployment could have contributed to the deployment difficulty, however from the information available, a definitive cause of this observation cannot be determined.In addition, it can be noted that deployment forces could not be verified during the device evaluation as the returned stent was already deployed.As the conditions of use cannot be replicated in the laboratory settings a definitive root cause of deployment difficulty cannot be determined.It may be noted that the following information is included in the instruction for use: "once stent deployment has begun, the stent must be fully deployed.Repositioning of the zilver ptx drug eluting peripheral stent is not possible since the delivery system's outer sheath cannot be re-advanced over the stent once deployment begins." "care should be taken to hold the hub stationary and to remove any slack in the introducer catheter to ensure the stent is not stretched or compressed lengthwise during deployment {i.E., so that the stent is deployed to its proper length).Before the stent deploys, slight movement may occur, so confirm that the stent markers are still aligned to the desired position.Reposition if necessary before deploying." prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records for zilver ptx and zilver ptx drug eluting stent revealed no discrepancies that could have contributed to this complaint.Intervention was carried out to remove the broken pieces of the stent.According to information provided, a small portion of the stent will be removed during femoral-popliteal bypass surgery.The relevant personnel have been notified of this complaint event.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracey o'sullivan ; 61334440
• MDR Report Key: 4147191
• MDR Text Key: 4789121
• Report Number: 3001845648-2014-00177
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P100022/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2016
• Device Catalogue Number: ZIV6-35-80-6.0-80-PTX
• Device Lot Number: C1009243
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2014
• Event Location: Hospital
• Date Manufacturer Received: 09/03/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR