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

Model Number	G48031
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k162717.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The white got detached from catheter."as per complaint form": the white inner catheter-tip got detached from catheter.
Additional Manufacturer Narrative
Pma/510(k) #: k162717.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The white got detached from catheter."as per complaint form": the white inner catheter-tip got detached from catheter.
Additional Manufacturer Narrative
K162717 - us clearance number.Device evaluation: the evo-20-25-10-e device of lot number c1604125 involved in this complaint was returned for evaluation, with its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on the 19th september 2019.The returned device lab findings and observations can be referred through the attached files.The white tip was found to be detached from the catheter.From additional information to below mentioned questions - at what point did they noticed that the white inner catheter -tip got detached from catheter? - please describe what happened step-by-step to help us gain a better insight as to how the white tip got detached? "during insertion of the stent system ,over the lying guide wire, at 30cm the doctor saw the with tip solved." documents review including ifu review: prior to distribution all evo-20-25-10-e 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-20-25-10-e device of lot number c1604125 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1604125; upon review of complaints this failure mode has not occurred previously with this lot #c1604125.The instructions for use ifu0061-5 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If any 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 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 that the potential damaged could have occurred during device prep which then deteriorated during advancement, 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 or Problem Description
The white got detached from catheter."as per complaint form": the white inner catheter-tip got detached from catheter.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿tip separation'.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Pma/510(k)#: k162717.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The white got detached from catheter."as per complaint form": the white inner catheter-tip got detached from catheter.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9149703
• Report Number: 3001845648-2019-00504
• Device Sequence Number: 2131736
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)210412(10)C1604125
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2021
• Device Model Number: G48031
• Device Catalogue Number: EVO-20-25-10-E
• Device Lot Number: C1604125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019; 09/04/2019; 09/04/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/31/2019; 11/28/2019; 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1