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

Model Number G48028

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - us clearance number.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

They introduced the catheter in the scope (olympus 160), after across the stenosis they tried to open the stent but was not possible open it.

Manufacturer Narrative

K163468 - us clearance number.This is a cancellation report being sent with the below justification: lab evaluation completed on 05-dec-2019 and determined that the shuttle cap was found to be broken and therefore removes the flexor precedence reported under previously.The file has been re-assessed and has an overall risk category iia (low).No reporting malfunction precedence exists for this complaint event for this product family.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.Fda mdr reporting not required: no adverse effects to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.This event has been re-assessed and this report is to notify the fda that this event no longer meets the fda reporting criteria of a malfunction report as per section 803.50 of 21 cfr 803.No adverse effects to the patient was reported as occurring.Complaints of this nature will continue to be monitored for potential emerging trends.Device evaluation: the evo-25-30-8-c device of lot number c1574536 involved in this complaint device involved in this complaint was returned for evaluation, with the 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 05th december 2019.The returned device lab findings and observations can be referred through the attached files.Refer the attachments 'pr282809_ lab evaluation notes', 'pr282809_lab_decon evaluation photos, 'pr282809_lab_attendees for lab attendance and notes'.On evaluation of the device the shuttle cap was found to be broken.Documents review including ifu review: prior to distribution all evo-25-30-8-c 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-25-30-8-c device of lot number c1574536 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 #c1574536; upon review of complaints this failure mode has not occurred previously with this lot #c1574536.The instructions for use ifu0052-10 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an 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 attributed to material failure.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 Description

They introduced the catheter in the scope(olympus 160), after across the stenosis they tried to open the stent but was not possible open it this is a cancellation report being sent with the below justification: lab evaluation completed on 05-dec-2019 and determined that the shuttle cap was found to be broken and therefore removes the flexor precedence reported under previously.The file has been re-assessed and has an overall risk category iia (low).No reporting malfunction precedence exists for this complaint event for this product family.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.Fda mdr reporting not required: no adverse effects to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.This event has been re-assessed and this report is to notify the fda that this event no longer meets the fda reporting criteria of a malfunction report as per section 803.50 of 21 cfr 803.No adverse effects to the patient was reported as occurring.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9383113
• MDR Text Key: 220065395
• Report Number: 3001845648-2019-00632
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)210110(10)C1574536
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1574536
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1