MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Model Number	G48028
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
User advanced the device about 30cm and saw the space-occupying lesion which block the lumen.User changed endoscopy to continue the procedure but still cannot advance the device.User then tried using angiography catheter with wire guide to pass through the block area but failed.User cannot release the stent by pulling trigger.Was the directional button fully engaged? yes.Did the red indicator move when the trigger was pressed? no.Did the red indicator continue to move after the delivery stopped? stent was not released.Were any cracking/popping sounds heard from the handle? no.Was the stent partially exposed? no.If the stent was partially exposed, was it possible to recapture the stent fully before removal? stent was not partially exposed.Were any additional procedures needed? no.What is the patient outcome? patient was discharged by hospital already.
Additional Manufacturer Narrative
Event was previously reported based on the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed¿.Device evaluated on (b)(6) 2020 " shuttle cap broken".Event no longer meets the requirements of a malfunction report based on the low risk assigned to a shuttle cap break.This report is being submitted as a cancellation report.Pma/510(k) #: k163468.
Event or Problem Description
Event was previously reported based on the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/stretched/broken/compressed¿.Device evaluated on (b)(6) 2020 " shuttle cap broken".Event no longer meets the requirements of a malfunction report based on the low risk assigned to a shuttle cap break.This report is being submitted as a cancellation report.User advanced the device about 30cm and saw the space-occupying lesion which block the lumen.User changed endoscopy to continue the procedure but still cannot advance the device.User then tried using angiography catheter with wire guide to pass through the block area but failed.User cannot release the stent by pulling trigger.1.Was the directional button fully engaged? yes.2.Did the red indicator move when the trigger was pressed? no.3.Did the red indicator continue to move after the delivery stopped? stent was not released.4.Were any cracking/popping sounds heard from the handle? no.5.Was the stent partially exposed? no.6.If the stent was partially exposed, was it possible to recapture the stent fully before removal? stent was not partially exposed.7.Were any additional procedures needed? no.8.What is the patient outcome? patient was discharged by hospital already.

• Brand Name: EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10905919
• Report Number: 3001845648-2020-00890
• Device Sequence Number: 19603966
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)210808(10)C1638976
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Report Date (Section B): 11/26/2020

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 Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1638976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR