MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number	G48026
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510(k) number: k163468.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending, follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed¿.As reported to customer relations, "we removed the red tab and began to deploy the stent in standard fashion.While deploying it was noted, no evidence of sheath sliding back.Distal aspect of stent was not opening.We arrived at the point of not return and had no evidence of distal stent opening.At this point they carefully examined the device and noticed the blue over sheath was completely sheered where it enters the hub.Unable to deploy the stent and the case was aborted.".
Additional Manufacturer Narrative
510(k) number: k163468 cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2019.Broken outer sheath observed in the laboratory.Documents review including ifu review: prior to distribution all evo-22-27-9-d 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-22-27-9-d device of lot number c1539098 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 #c1539098; upon review of complaints this failure mode has not occurred previously with this lot #c1539098.The instructions for use ifu0053-9 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 ifu0053-9.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 attributed to device handling.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
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed¿.As reported to customer relations, "we removed the red tab and began to deploy the stent in standard fashion.While deploying it was noted, no evidence of sheath sliding back.Distal aspect of stent was not opening.We arrived at the point of not return and had no evidence of distal stent opening.At this point they carefully examined the device and noticed the blue over sheath was completely sheered where it enters the hub.Unable to deploy the stent and the case was aborted.".

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8292544
• Report Number: 3001845648-2019-00033
• Device Sequence Number: 1500476
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)200911(10)C1539098
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: 09/11/2020
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1539098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1