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

Catalog Number EVO-FC-R-20-25-8-E

Device Problem Migration (4003)

Patient Problems Fistula (1862); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Stent #2: evo-fc-r-20-25-8-e (b)(6) procedure: was the stent placed at the intended location at completion of the procedure? yes.Were any additional procedure (s) performed during the study procedure? no.Were any adverse events documented during the stent procedure? no.Were any device deficiencies documented during the placement procedure? no.Adverse event: migration of the prosthesis.Event treatment: new stent placed (non-study stent) cook evolution.Was the event considered to be related to the study device? related.Was the event considered to be related to the study procedure? not related.Did a pre-existing condition, or other condition or circumstance cause or contribute to this event? no.Did the event occur due to a device deficiency? no.Patient outcome: at the conclusion of follow-up what was the status of the study stent: stent removed endoscopically.Days post stent placement: 20.Reason for removal: adverse event.Event status at time of study exit: resolved (patient recovered/stabilized).

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 07-apr-2023.

Manufacturer Narrative

Device evaluation: the device evaluation for evo-fc-r-20-25-8-e of lot c1477690 could not be completed as the device or photographic evidence of the device was not returned for evaluation.Lab evaluation: n/a.Documents review including ifu review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records of lot c1477690 did not reveal any discrepancies that could have contributed to this complaint issue the review of relevant manufacturing records of lot number c1477690 confirms the failure mode has not previously occurred for this work order.The instructions for use, ifu0067 which accompanies this device, it informs the user about the potential complications "additional complications include, but are not limited to: stent misplacement and/or migration".There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, stent migration is listed as a potential complication following the placement of this device.Summary: complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did experience an 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 - FULLY 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: 15915336
• MDR Text Key: 304821291
• Report Number: 3001845648-2022-00841
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)200420(10)C1477690
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2020
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1477690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2018
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 62 KG