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 Problem Laceration(s) of Esophagus (2398)

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

Stent #1: evo-fc-r-20-25-8-e (c1599258) procedure: were any additional procedure (s) performed during the study procedure? yes - dilation.Were any adverse events documented during the stent procedure? yes.Were any device deficiencies documented during the placement procedure? no.Adverse event #1: stent migration.Adverse event onset (days post stent placement): 6.Device issue: stent migration.Confirmed by imaging.Direction of migration: distal.Provide degree of migration: to stomach.Led to intestinal obstruction? no.Were any of the following symptoms or conditions documented in the medical record? dysphagia, loss of appetite + the fissure persists.Was the stent repositioned or replaced? yes.Event treatment: endoscopic-study stent repositioned.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 the event occur due to a device deficiency? no.Event status at time of study exit: resolved (patient recovered/stabilized).Adverse event #3: deep esophageal tear.Adverse event onset (days post stent placement): 6.Event treatment: study stent repositioned.Was the event considered to be related to the study device? related.If related, please provide a detail description of how study device caused or contributed to this event: stent migration.Was the event considered to be related to the study procedure? 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.Event status at time of study exit: resolved (patient recovered/stabilized).Patient outcome: event status at time of study exit: resolved (patient recovered/stabilized).

Manufacturer Narrative

Pma/510(k) # k162717.Device evaluation: the device evaluation for evo-fc-r-20-25-8-e of lot c1599258 could not be completed as the device or photographic evidence of the device was not returned for evaluation manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot c1599258 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 c1599258 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: the instructions for use, ifu0067 which accompanies this device, states ¿after stent placement, alternative methods of treatment such as chemotherapy and tumour shrinkage should not be administered this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.¿¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the instructions for use, (ifu0067), stent migration is listed as a complication following the placement of this device.It is known from the available information that the stent migration caused or contributed to the deep oesophageal tear observed.Summary of investigation: according to the customer the stent migrated to the stomach.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient recovered/stabilized.Investigation findings conclude a definitive root cause was not established.A possible root cause could be attributed to the instructions for use, (ifu0067), stent migration is listed as a complication following the placement of this device.It is known from the available information that the stent migration caused or contributed to the deep oesophageal tear observed.Complaint is confirmed based on customer and/or rep testimony.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 27jan2023.

• 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: 15914990
• MDR Text Key: 304798560
• Report Number: 3001845648-2022-00826
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)210328(10)C1599258
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/27/2023

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: 03/28/2021
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1599258
• 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: 11/08/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 80 KG