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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL
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COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL Back to Search Results
Catalog Number EVO-20-25-15-E
Device Problem Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2018
Event Type  Injury  
Manufacturer Narrative
Pma/510(k) #: k162717.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
Report is being submitted based on the requirement for a surgical intervention as the patient will require another procedure to retrieve stent.Dr.Placed the stent to low and the stent was deployed into the stomach.The stent remains in the stomach and will be retrieved at a later time.
 
Manufacturer Narrative
Pma/510(k)#: k162717.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to mfr site as follows: importer site contact and address: (b)(6).(b)(4).Device evaluation: the evo-20-25-15-e device of unknown lot number was not returned to cook ireland and so could not be evaluated.Additional information was also received: 1.At what stage of the procedure did the complaint occur? (when unpacking or preparing the evolution, while inserting the evolution in the patient, during stent placement, while removing the introducer, or during stent repositioning/removal) during stent placement.2.What endoscope type and channel size was used? na.3.What was the position of the elevator? was it opened or closed? na.4.Details of the wire guide used (diameter, type, make)?.0.35 jag wire.5.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes.6.How long was the stent in the patient by the time this complaint occurred? initial placement.7.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? stricture information: na.1.What was the length and diameter of the stricture? unknown.2.Where was the stricture located in the body? esophagus.3.Was there resistance felt passing wire guide through stricture? unknown.4.Was there resistance felt passing the evolution through stricture? unknown.5.Was the stricture dilated before stent placement? no.Questions related to during insertion into patient: 1.Was the product inspected for kinks or damage before use? yes.2.Was resistance felt during insertion into patient? if yes, at what point? unknown.Questions related to during stent placement: 1.Did the product fail during stent deployment or recapture? no.2.Was the directional button pressed during use? only after stent was found to be in the wrong position.3.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? yes.4.Was the yellow marker kept in view during deployment? no yellow marker.5.Are images of the device or procedure available? no.Questions related to during introducer withdrawal: 1.Was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? yes scope.2.Did the stent open sufficiently to allow withdrawal of introducer safely? na.3.Was the safety wire fully removed before removing the delivery system? yes.4.Did any part of the product snag/get caught with the stent when removing the delivery system? unknown.5.Are images of the device or procedure available? no.Questions related to during stent repositioning/removal: 1.What instrument was used for stent repositioning / removal? forceps, snare, unknown.2.Was the lasso (suture) loop used during repositioning / removal? yes.Patient pre-existing conditions: oesophageal cancer.Lab evaluation: as the device was not returned; a lab evaluation could not be conducted.Root cause: the possible root cause of this complaint is user error.As per complaint ¿dr placed the stent to low and the stent was deployed into the stomach.¿ as the device was not used as per ifu the stent was misplaced in error.The customer complaint is considered to be confirmed based on customer testimony, however, it may be noted that the device was not used as per instructions for use.Document review: the device involved in this complaint was not available for return to cook ireland for evaluation.With the information provided a document based investigation was carried out.Prior to distribution all evo-20-25-15-e devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Ifu review: as per instructions for use, ifu0061-5, confirm desired stent position fluoroscopically and deploy stent by removing red safety guard from the handle.Summary: from the information provided, the stent was successfully removed from the patients stomach.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
Report is being submitted based on the requirement for a surgical intervention as the patient will require another procedure to retrieve stent.Dr placed the stent to low and the stent was deployed into the stomach.The stent remains in the stomach and will be retrieved at a later time.
 
Manufacturer Narrative
Pma/510(k) # ; k162717.(b)(4).Exemption number: e2016031.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
Report is being submitted based on the requirement for a surgical intervention as the patient will require another procedure to retrieve stent.Dr placed the stent to low and the stent was deployed into the stomach.The stent remains in the stomach and will be retrieved at a later time.
 
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Brand Name
EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
Type of Device
ESW PROSTHESIS, ESOPHAGEAL
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key7738085
MDR Text Key115648885
Report Number3001845648-2018-00353
Device Sequence Number1
Product Code ESW
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,Followup
Report Date 08/29/2018
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 Catalogue NumberEVO-20-25-15-E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/27/2018
Event Location Hospital
Initial Date Manufacturer Received 07/05/2018
Initial Date FDA Received08/01/2018
Supplement Dates Manufacturer Received07/05/2018
07/05/2018
Supplement Dates FDA Received08/29/2018
09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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