MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED - RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Catalog Number EVO-22-27-12-D

Device Problem Delivery System Issue, No Description (2664)

Patient Problem Migration (2249)

Event Date 01/02/2014

Event Type  malfunction  

Event Description

The cook district manager realized that the product was expired right when the physician was putting the device down the scope.The device was inside the pt but had not been deployed.The district manager stopped the procedure to inform the physician that the device was expired but the physician chose to proceed with the procedure using the expired product.The physician was using a great deal of force to advance the catheter through the tumor or stricture.The yellow marker was lined up appropriately but the stent was placed partially past the stricture and partially in the stricture.Upon examination of the removed introducer.It was determined that the stent migrated forward and that there was a break from the top of the introducer to the yellow marker.An unintended section of the device did not remain inside the pt's body.The pt did not require any add'l procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This complaint is reportable to the fda on the basis of the reporting precedence established for stent migration for this product family.The complaint info reported was as follows: "the dm stopped the procedure to inform the physician that the device was expired but the physician chose to proceed with the procedure using the expired product.The physician was using a great deal of force to advance the catheter through the tumor or stricture.The yellow marker was lined up approx but the stent was placed partially past the stricture and partially in the stricture.Upon examination of the removed introducer, it was determined that the stent migrated forward and that there was a break from the top of the introducer to the yellow marker." there were no evo-22-27-12-d (evolution) devices of lot number c684704 in stock at the time of the complaint investigation.One evo-22-27-12-d device of lot number c684704 was returned for eval.It was returned with its original packaging and was open on receipt.The customer complaint was confirmed as the introducer had broken at the polyamide to peek joint.Evidence of glue was noted on the polyamide, confirming that glue had been applied to this joint as required during the mfg process.No issues were noted with other parts of the returned device.An attempt was made to pass a 0.035" wire guide through the detached polyamide portion of the introducer.Resistance was noted both proximally and distally to the yellow marker.A kink was noted on the polyamide distal to the yellow marker at approx 23cm from the distal tip.The distance from the end of the yellow marker to the proximal end of the marker band was confirmed to be within spec.One possible contributing factor in this complaint is that the device was used over four months beyond its expiry date.It is also reported that the pt did have very challenging anatomy and the physician was using a great deal of force to advance the catheter through the tumor or stricture.It is noted that due to the design of the device and the manner in which it functions, force would not have been exerted on this particular polyamide to peek joint during deployment of the stent.However, forces may have been exerted on this joint during use or removal of the introducer from the pt.As the device had passed its expiry date, it may not have been able to meet high resistance.The cause of this complaint cannot be conclusively determined as we are unable to replicate the conditions of use in the laboratory.Prior to distribution, all evo-22-27-12-d devices are subjected to visual inspection and functional checks to ensure device integrity.During the mfg process, a manual tug is performed on the polyamide to peek joint to ensure it is secure.The proof load test conducted on tip adhesion would also check the security of the polyamide to peek joint.In addition, there is a final quality control check to verify that a 0.035" wire guide passes freely through the product.A review of the mfg records for evo-22-27-12-d of lot# c684704 revealed no discrepancies that could have caused the complaint issue.It can be noted that the pt did not experience any adverse effects due to this observation.The evolution duodenal stent system is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.The device is intended for palliative treatment only.Alternate methods of therapy should be investigated prior to placement.The notes section of ifu0053-7 instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".No corrective action is warranted at this time.There have been no adverse effects to the pt as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION DUODENAL CONTROLLED - RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan, unk ; cook ; EI ; 61334440
• MDR Report Key: 3663166
• MDR Text Key: 4347448
• Report Number: 3001845648-2014-00017
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101530
• 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: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2013
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C684704
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/02/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/02/2014
• Initial Date FDA Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2011
• 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: 64 YR