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

Catalog Number EVO-FC-R-20-25-10-E

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); No Clinical Signs, Symptoms or Conditions (4582)

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

Mdr- (b)(4) - device issues: other device issue, device: not related, procedure: not related, deficiency: no.30 days post procedure stent removed as no longer needed.Radiodiagnostic contrast output through the stent - prolonged hospital stay? treated by hospital admission.Event status: not documented, treatment: medical : hospital admission, death: no.

Manufacturer Narrative

Pma/510(k) # (b)(4).Device evaluation: the 01x evo-fc-r-20-25-10-e device of lot number c1604915 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to the pmcf study mdr-2054 to capture ¿off label use¿.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label review: there is evidence to suggest that the customer did not follow the instructions for use/product label.Upon reviewing the complaint detail/events provided, it was noted that the device was used against the intended use outlined in the ifu.As per the instruction for use (ifu0067), the intended use is listed as ¿this device is used to maintain luminal patency of the esophagus in cases of: obstruction caused by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal tracheoesophageal fistulas¿ while the complaint device was used for post-surgical stenosis in the tubular gastrectomy area and is therefore off-label use.Off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Trending will monitor if any future investigation is required.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of off label use was identified from the available information.As stated above, the device was placed in the tubular gastrectomy area for post-surgical stenosis which is a contradiction to the intended use of the device outlined in the instructions for use.As per the patient casebook, ae1 was reported as ¿radiodiagnostic contrast output through the stent¿.As per the casebook and clinical input received, the evolution esophageal stent did not cause or contribute to the reported ae.Instead, the cause listed in the casebook was due to patients pre-existing conditions ¿possible suture dehiscence from bariatric surgery¿.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 01x used device summary of investigation: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient was admitted to hospital to treat the radiodiagnostic contrast output through the stent and was stabilised.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 on (b)(6) 2023.

• 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: 16852335
• MDR Text Key: 314393067
• Report Number: 3001845648-2023-00299
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551715
• UDI-Public: (01)10827002551715(17)210417(10)C1604915
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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: 04/17/2021
• Device Catalogue Number: EVO-FC-R-20-25-10-E
• Device Lot Number: C1604915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• 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): Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 140 KG