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

Model Number G48032

Device Problems Product Quality Problem (1506); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

At the time of procedure, physician couldn¿t able to deploy the stent, due to the delivery device malfunction.Oesophageal cancer patient for sems placement as palliative measure stricture seen at 30 cm,scope didn¿t pass,placed guidewire beyond stricture and dilated up to 12 mm with hercules balloon dilator,hbd-w-12-13.5-15,scope passed beyondstricture,placed external markers.Upon placed guidewire passed the evolution12.5 cm esophageal delivery device and tried to deploy the stent under fluro guidance.Tried to deploy stent,but there is resistance in triggering the stent ,so taken back and tried to deploy outside,there is malfunction of delivery device ,trigger is very hard to manipulate.So abandoned the procedure.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted with an update to the description of events addtional information received 01-sep-2021: procedure repeated with a 12.5cm after two days.

Manufacturer Narrative

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

Event Description

Supplemental follow-up report is being submitted due to the receipt and evaluation of the complaint device.Lab evaluation complete 07-oct-2021: 'safety wire in place, unable to actuate the handle and unable to deploy the stent.Handle opened and no defect observed.Stent unable to deploy manually.Device re-evaluated 29-oct-21: "white tip appears stuck to outer sheath".

Manufacturer Narrative

The investigation is pending, a follow up mdr will be submitted.

Event Description

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

Event Description

Supplemental report is being submitted due to the completion of the investigation on the 25-may-2023.

Manufacturer Narrative

Pma 510k #k162717 device evaluation: the device evaluation evo-20-25-12.5-e of lot c1791588 was complete.1 unit of device evo-20-25-12.5-e of lot c1791588 involved in this complaint was returned for evaluation, with the original packaging.On evaluation of the device the safety wire was in place on return of the device.Unable to actuate handle and unable to deploy the stent.Handle opened and no defect observed.Attempted to deploy the stent manually but unable to.On the re-evaluation the introducer was cut to determine defect.White tip was cut and it appears to be stuck to outer sheath.Stent intact.The returned device lab examination findings and observations can be referred through attached photos from the lab evaluations the white tip of the device appeared to be stuck to the outer sheath.Device samples were sent for chemical analysis for comparison of the substance with loctite glue 4061, material was analyses and locite 4061 was best match.Nc22-027 was initiated because of this complaint.Pr 355789 was also captured in this ncr.Hra part i d00516658 rev001 has been initiated, scope of d00516658 includes all evolution esophageal rpns.Hra part i d00516658 rev001 established that the issue presents a possible risk to health (severity = 3 is applicable) and also that the issue presents a possible regulatory risk.Based on the above the issue was escalated and hra part ii d00517489 was initiated.Hra part ii d00517489 concluded that no field action is required.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Prd0261 (d00052092), product instructions for evolution esophageal partially covered stent loading section 2.2 details how to glue the tip to the peek, step 3.2.1 details how to perform the tip proof load test.A review of the manufacturing records of lot number c1791588 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c1791588 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the instructions for use, ifu0061 which accompanies this device, instructs the user : ¿¿ "visually inspect with particular attention to kinks, bends and breaks.If 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 analysis a definitive root cause could be attributed to a manufacturing discrepancy.Nc22-027 was completed to investigate this issue further.The root cause analysis explored 2 possible causes 1.It is possible that the mtm applied an additional drop of glue to tip proof loading.2.An extra drop of glue accidently dropped on the peek after wiping excess glue from the tip.Confirmation of complaint complaint is confirmed based on visual and/or functional inspection.Summary of investigation according to the complaint the physician was unable to deploy the stent.Confirmed quantity of 1 device, confirmed used.The patient did not experience any adverse effects due to this occurrence.Investigation findings a definitive root cause could be attributed to a manufacturing discrepancy.Nc22-027 was completed to investigate this issue further.The root cause analysis explored 2 possible causes 1.It is possible that the mtm applied an additional drop of glue to tip proof loading.2.An extra drop of glue accidently dropped on the peek after wiping excess glue from the tip.Difficulties.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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 12419941
• MDR Text Key: 271228929
• Report Number: 3001845648-2021-00642
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)230113(10)C1791588
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/25/2023

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: 01/13/2023
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1791588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/06/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/07/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 08/07/2021; 08/07/2021; 08/07/2021; 08/07/2021
• Supplement Dates FDA Received: 09/29/2021; 11/03/2021; 12/06/2021; 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 48 KG