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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL
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COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL Back to Search Results
Catalog Number EVO-22-27-9-D
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Patient Problem Occlusion (1984)
Event Type  Injury  
Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Pma/510(k) #: k163468.
 
Event Description
According to the user, the reported stent separation has not occurred actually.Overgrowth and ingrowth of tumor occurred and the center of the stent was covered by the tumor.Therefore, the user mistook the growth of tumor for stent separation competitor's stent was placed on (b)(6) 2019.There have been no adverse effects to the patient reported.According to the sales rep, it is difficult to get further information for this complaint.
 
Manufacturer Narrative
Us preclearance number # k163468.Device evaluation: the evo-22-27-9-d device of unknown lot number was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.From complaint description: "according to the user, the reported stent separation has not occurred actually.Overgrowth and ingrowth of tumor occurred and the center of the stent was covered by the tumor.Therefore, the user mistook the growth of tumor for stent separation competitor's stent was placed." documents review including ifu review: as the evo-22-27-9-d device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo-22-27-9-d devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per the instructions for use, (b)(4) which informs the user about the potential complications "additional complications include, but are not limited to: tumor ingrowth or overgrowth, stent occlusion." on review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, tumor ingrowth or overgrowth are listed as a complication following the placement of this device.Summary: customer complaint is confirmed based on customer testimony.According to the initial reporter, competitor's stent was placed and there have been no adverse effects to the patient reported.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
According to the user, the reported stent separation has not occurred actually.Overgrowth and ingrowth of tumor occurred and the center of the stent was covered by the tumor.Therefore, the user mistook the growth of tumor for stent separation competitor's stent was placed on (b)(6) 2019.There have been no adverse effects to the patient reported.According to the sales rep, it is difficult to get further information for this complaint.
 
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Brand Name
EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
Type of Device
MUM STENT, METALIC EXPANDABLE, DUODENAL
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key9586065
MDR Text Key189071769
Report Number3001845648-2020-00027
Device Sequence Number1
Product Code MUM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/14/2020
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? No
Device Operator Health Professional
Device Catalogue NumberEVO-22-27-9-D
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Initial Date Manufacturer Received 12/18/2019
Initial Date FDA Received01/14/2020
Supplement Dates Manufacturer Received12/18/2019
Supplement Dates FDA Received02/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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