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

Model Number G48032

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Complaint received from distributor via e-mail on 30oct2020--did 02nov2020.As reported to customer relations: "endoscopy was performed, a tumor is marked and then the wire guide was installed through the scope.With rx the stent is advanced through the wire guide and placed in position.The physician begins to deploy the stent smoothly until the red button reaches the "point of no return" the stylet was completely removed and the delivery continues until the end.At the time of removing the deployment system the stent wasn´t separate and it started to came together being trapped finally in the upper esophageal sphincter, the physician removed with a alligator jaw forceps.Then a brand new stent was installed without any problem." patient outcome: did any section of the device remain inside the patient¿s body? yes.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? no.If yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.General questions: 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.During stent repositioning/removal.What endoscope type and channel size was used? olympus 150 2.8mm.What was the position of the elevator? was it opened or closed? details of the wire guide used (diameter, type, make)? savary cook medical.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? how long was the stent in the patient by the time this complaint occurred? just few minutes.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? stricture information: what was the length of the diameter of the stricture? 8 cm.Where was the stricture located in the body? esophagus.Was there resistance felt passing the wire guide through stricture? no.Was there resistance felt passing the evolution through stricture? no.Was the stricture dilated before stent placement? no.Questions related to during stent repositioning/removal.What instrument was used for stent repositioning/removal? forceps, snare.Aligator jaw biopsy forceps.Was the lasso (suture) loop used during repositioning / removal? yes.Was the lockwire removed completely prior to removal of the introduction system? yes.Was the introduction system recaptured prior to removal from the patient? no.Did the patient require any intervention due to this event? no.Was the directional button fully engaged? si.Did the red indicator move when the trigger was pressed? yes.Did the red indicator continue to move after the delivery stopped? no.Were any cracking/popping sounds heard from the handle? no.Was the stent partially exposed? if the stent was partially exposed, was it possible to recapture the stent fully before removal? no.What is the patient outcome? the patient underwent to another procedure because was feeling bad and another brand new 10cm evolution was installed.

Event Description

Supplemental report being submitted due to the investigation being completed on 19-may-2021.

Manufacturer Narrative

Device evaluation: the evo-20-25-12.5-e device of lot number c1582798 involved in this complaint was not returned for evaluation.With the information provided a document based investigation was conducted.Documents review including ifu review: prior to distribution all evo-20-25-12.5-e devices are subject to visual inspection and functional checks to ensure device integrity.There inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-20-25-12.5-e device of lot number c1582798 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1582798; upon review of complaints this failure mode has not occurred previously with this lot #c1582798.As per the instructions for use, ifu0061-5, which accompanies this device instructs the user to: "if stent repositioning is required during deployment, it is possible to recapture stent.Note: it is not possible to recapture stent after passing point-of-no-return, indicated when red marker on top of introducer has passed the point-of-no-return indicator on handle." there is no evidence to suggest that the customer 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 the difficult target site which could lead to a stent getting caught up on the delivery system tip.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary complaint is confirmed based on the customer¿s testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 10911780
• MDR Text Key: 219952005
• Report Number: 3001845648-2020-00896
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)210205(10)C1582798
• 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
• Report Date: 05/19/2021

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: 02/05/2021
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1582798
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 65