MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48027

Device Problem Break (1069)

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

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

User advanced the delivery system to desired position and release the stent, and the red indicator reach non-retrievable point.User checked the position of stent under x-ray and decide to adjust the position of stent.User retract the stent while found out the white tip of delivery system off from device.User then changed another same device to complete the procedure.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: what is the reorder number of the wire guide used with this device? (b)(4).If not with the device in question, how was the procedure finished? with another same device to complete the procedure.For complaints occurring during use (once in contact with patient) also ask: what is the endoscope manufacturer and model number that was used during the procedure? olympus jf-260v, jf-260v.Had dilation of the stricture been performed prior to stent placement? yes.What was the diameter of the stricture at the time of stent placement (in mm)? 12mm.What was the length of the stricture at the time of stent placement (in cm)? 7 cm.Please describe the location in the body where the stent was to be placed.Duodenum.Was resistance encountered when advancing the wire guide through the stricture? no.Was resistance encountered when advancing the introducer and stent into position? yes.Did any section of the device detach inside the patient? no.After placement, was stent position verified? if yes, please describe how.X-ray.After placement, was the endoscope advanced through the stent? stent was placed.Please estimate amount of time the stent was in place prior to this occurrence.N/a.Did the patient undergo chemotherapy or radiation treatments after stent placement? unknown.Could you confirm that the point of no return had not been passed prior to attempting to recapture and reposition the stent? yes.Did the user attempt to fully deploy the device before it was removed? if not, why did they not fully deploy the stent? no.User find the release position is not ideal.Was the white tip of the delivery system known to be broken before removing or was this noted afterwards? afterwards.How was the tip removed from the patient? the tip is on the wire guide and retracted.Was the directional button fully engaged? yes.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? yes.If the stent was partially exposed, was it possible to recapture the stent fully before removal? yes.Were any additional procedures needed? no.What is the patient outcome? patient is well now.

Manufacturer Narrative

Pma/510(k) # = k163468.Device evaluation the evo-22-27-12-d device of lot number cf1720576 involved in this complaint was returned for evaluation, open in its original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation including ifu review: the device related to this occurrence underwent a laboratory evaluation on the 26 nov 2020.On evaluation of the device the white tip was separated from the introducer and returned separately.Red marker on top of introducer at 04th indicator on return.Lock-wire in place on return.Safety tab in place on return.Handle was actuating fine.Stent deployed without any issues.Stent intact.Lock wire removed without any issues.Document review including ifu review: prior to distribution evo-22-27-12-d 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-22-27-12-d devices of cf1720576 lot number did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number cf1720576.The instructions for use ifu0053-10 which accompanies this device instructs the user that " if wire guide or stent cannot advance through obstructed area , do not attempt to place stent.¿ there is no evidence to suggest that the customer did not follow the instructions for use.Image review: no images were reviewed as no images were provided 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 to the torturous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the white tip to become separated from the introducer.Customer feedback indicated there was resistance felt while advancing the device through the stricture.Summary according to the initial reporter, the patient did not experience any adverse effects due to this occurrence complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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

• 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 Key: 10927547
• MDR Text Key: 218958440
• Report Number: 3001845648-2020-00906
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)220325(10)CF1720576
• 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: 07/26/2021

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: 03/25/2022
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: CF1720576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/02/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 57