MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Model Number G48038

Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)

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

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Customer informed rep that yesterday they were using evo-25-30-10-c in a procedure with a patient and when they deployed the stent, when they tried to recover it and triggered the handle, the handle broke.Patient was not harmed."as per complaint form": tempting to place this stent in the colon recto-sigmoid, they deployed half of the stent but they decided to recover it, and when recovering back the stent the mechanism failed and they had to pull all the system out of the colon.They described the stent could be recovered almost totally.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Patient/event info - notes: 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, or during stent repositioning/removal) stent repositioning what endoscope type and channel size was used? fujifilm serie 530 3.8mm.What was the position of the elevator? was it opened or closed? na.Details of the wire guide used (diameter, type, make)? 0035, jagwire, boston.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes.How long was the stent in the patient by the time this complaint occurred? na.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? na.Is the patient known to be covid-19 positive? no.Stricture information: what was the length and diameter of the stricture? 7cm x 7mm.Where was the stricture located in the body? recto-sigmoid.Was there resistance felt passing 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 insertion into patient was the product inspected for kinks or damage before use? yes.Was resistance felt during insertion into patient? if yes, at what point? yes, it was sigmoid area.Questions related to during stent placement: did the product fail during stent deployment or recapture? recapture.Was the directional button pressed during use? yes, to recapture.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? stent was already deployed to mid deployment.Was the yellow marker kept in view during deployment? yes.Are images of the device or procedure available? no.Questions related to during introducer withdrawal: was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? a new stent was placed without any problem next day, i was present at the second procedure.Did the stent open sufficiently to allow withdrawal of introducer safely? na.Was the safety wire fully removed before removing the delivery system? na.Did any part of the product snag/get caught with the stent when removing the delivery system? no.Are images of the device or procedure available? no.Questions related to during stent repositioning/removal: what instrument was used for stent repositioning / removal? forceps, snare¿ just pulling the duodenoscope and stent all together.Was the lasso (suture) loop used during repositioning na.In addition, could you also please ask the following: was the directional button fully engaged? yes, they said.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? they don't remember was the stent partially exposed? yes.If the stent was partially exposed, was it possible to recapture the stent fully before removal? they could recapture almost completed (-1,5cm) before failure occurred.Were any additional procedures needed? no.What is the patient outcome? they placed a new stent next day, and it went very well.What was the position of the directional button while retracting he stent? the button was in recapture position; they could recapture almost all the stent but just before they could completed recapture the handle crack.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Pma/510(k) #: k163468 device evaluation: the evo-25-30-10-c device of lot number c1668095 involved in this complaint device was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on the (b)(6) 2020.In summary the following results were observed in the lab evaluation: stent was partially deployed on return.Handle was actuating fine, advancement and retraction was possible.Stent fully deployed without any issues.Device functioned as intended.Following the device evaluation additional information was requested to aid with this investigation."-what was the position of the directional button while retracting the stent? the button was in recapture position; they could recapture almost all the stent but just before they could completed recapture the handle crack." documents review including ifu review: prior to distribution all evo-25-30-10-c 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.A review of the manufacturing records for evo-25-30-10-c device of lot number c1668095 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 #c1668095; upon review of complaints this failure mode has not occurred previously with this lot #c1668095.The instructions for use ifu0052-11 which accompanies this device 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".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 as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed potentially to patient anatomy as the device when returned for evaluation functioned as intended.From additional information provided, "as they already informed me, this procedure was done in a difficult anatomy area, sigmoid, as written in the complaint sheet.Due to the lesion the colon was not totally clean so they decided to complete the procedure next day; any way, the patient was going to stay in the hospital for observation porpoises." summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10676261
• MDR Text Key: 211263465
• Report Number: 3001845648-2020-00779
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)211113(10)C1668095
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2021
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1668095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/14/2020
• Event Location: Hospital
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 70