MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Model Number ESW

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 06/04/2018

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 under reporting precedence for this device family for the issue of 'deployment issue that results in the exposed stent removed from the patient with the delivery system'.Complaint: finished deploying stent, safety wire was removed.End of stent was stuck in introducer it would not fully deploy.Dr waited 10 mins and tried again but stent still would not detach from introducer.Dr ended up removing the introducer with stent & had to start procedure again with another device."as per complaint form: end of stent was stuck in introducer it would not fully deploy despite safety wire being released.

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 (b)(4).Importer site establishment registration number: (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

Additional information received to confirm the procedure was due to bleeding additional stent was placed at repeat procedure complaint: finished deploying stent, safety wire was removed.End of stent was stuck in introducer it would not fully deploy.Dr waited 10 mins & tried again but stent still would not detach from introducer.Dr ended up removing the introducer with stent & had to start procedure again with another device "as per complaint form: end of stent was stuck in introducer it would not fully deploy despite safety wire being released.

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 section g.1 as follows: importer site contact and address: ed sutkowski cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195 importer site establishment registration number: 3005580113 problem statement: complaint: finished deploying stent, safety wire was removed.End of stent was stuck in introducer it would not fully deploy.Dr waited 10 mins & tried again but stent still would not detach from introducer.Dr ended up removing the introducer with stent & had to start procedure again with another device "as per complaint form: end of stent was stuck in introducer it would not fully deploy despite safety wire being released.Device evaluation: the evo-20-25-8-e of c1468574 lot number was unavailable for evaluation.1.What is the reorder number of the wire guide used with this device? evo-20-25-8-e lot: c1468574 2.If not with the device in question, how was the procedure finished? repeat procedure on 11th june for complaints occurring during use (once in contact with patient) also ask: 3.What is the endoscope manufacturer and model number that was used during the procedure? olympus 1t-240 4.Had dilation of the stricture been performed prior to stent placement? no 5.What was the diameter of the stricture at the time of stent placement (in mm)? 9mm 6.What was the length of the stricture at the time of stent placement (in cm)? 3cm 7.Please describe the location in the body where the stent was to be placed.Oesophagaus 8.Was resistance encountered when advancing the wire guide through the stricture? no 9.Was resistance encountered when advancing the introducer and stent into position? no 10.Did any section of the device detach inside the patient? no 11.After placement, was stent position verified? if yes, please describe how.N/a 12.After placement, was the endoscope advanced through the stent? n/a 13.Please estimate amount of time the stent was in place prior to this occurrence.N/a 14.Did the patient undergo chemotherapy or radiation treatments after stent placement? n/a additional information with replies to the following two questions was received as well 1.What was the patient outcome, did the patient suffer any adverse effects? the patient had minor bleeding.The procedure was rebooked and the stent was successfully placed on the second attempt on 11/06/18 2.Was the stent exposed during removal from the patient or was it possible to retract it into the sheath before removal? the stent was exposed as it was fully deployed.With the information provided a document based investigation was carried out.The patient had the following pre-existing conditions: cancer of the oesophagus there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Root cause: a possible cause for this complaint is that the stent did not detach from the introducer.However, there was no device returned for investigation, and no images available for review therefore a definite root cause could not be determined.Document review: a review of the relevant manufacturing records for the evo-20-25-8-e of c1468574 revealed no discrepancies that could have contributed to this complaint issue.Prior to distribution all evo-20-25-8-e 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 there is no evidence to suggest that this issue affects the entire lot c1468574; upon review of complaints this failure mode has not occurred previously with this lot c1468574.Ifu review: as per the instructions for use, ifu0061-5, notes section the user is instructed of the following: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use".On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.The introducer was removed with the stent still attached and from the information provided, the patient had minor bleeding as a result of this occurrence complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Additional information received to confirm the procedure was due to bleeding additional stent was placed at repeat procedure complaint: finished deploying stent, safety wire was removed.End of stent was stuck in introducer it would not fully deploy.Dr waited 10 mins & tried again but stent still would not detach from introducer.Dr ended up removing the introducer with stent & had to start procedure again with another device "as per complaint form: end of stent was stuck in introducer it would not fully deploy despite safety wire being released.

• 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 Key: 7662430
• MDR Text Key: 113631663
• Report Number: 3001845648-2018-00311
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480305
• UDI-Public: (01)10827002480305(17)200328(10)C1468574
• 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,Followup
• Report Date: 07/30/2018

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: 03/28/2020
• Device Model Number: ESW
• Device Catalogue Number: EVO-20-25-8-E
• Device Lot Number: C1468574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/04/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/04/2018
• Supplement Dates Manufacturer Received: 06/07/2018; 06/07/2018
• Supplement Dates FDA Received: 07/30/2018; 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention