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	12/12/2018
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, a 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'."impossible to deploy stent".Rep will arrange return."as per complaint form": stent would not deploy.Additional information received 19-dec-2018: was the directional button fully engaged? yes.Did the red indicator move when the trigger was pressed? yes.Did the red indicator continue to move after the delivery stopped? yes.Were any cracking/popping sounds heard from the handle? not known.Was the stent partially exposed? no.If the stent was partially exposed, was it possible to recapture the stent fully before removal? na.Were any additional procedures needed? no.
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).The device involved in the complaint was evaluated in the laboratory on the (b)(6) 2019.Flexor was observed broken.Following the laboratory evaluation additional complaint file was raised to address second failure mode, slight kink was observed during the lab evaluation, possibly as a result of transport returns additional complaint file was raised post investigation to address the second failure mode, "user error - use of non- recommended wire guide" 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 c1311877 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 #c1311877; upon review of complaints this failure mode has not occurred previously with this lot #c1311877.The instructions for use ifu0052-10 which accompanies delivery system description and instructs the user to "the stent is mounted on an inner catheter, which accepts a.035 inch wire guide, and is constrained by an outer catheter." there is evidence to suggest that the customer did not follow the instructions for use ifu0052-10 "the stent is mounted on an inner catheter, which accepts a.035 inch wire guide, and is constrained by an outer catheter." however as per additional information received the 0.025 inch wire guide was used.This will be investigated a separate file.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause of failure could be attributed to torturous anatomy, causing a build-up of pressure and resulting in the flexor breaking.Additionally a possible cause for the issue occurring may be due to delamination of the ptfe liner of the outer sheath.A project was carried out to make improvements to the flexor design.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' "impossible to deploy stent" rep will arrange return."as per complaint form": stent would not deploy.Additional information received (b)(6): 1.Was the directional button fully engaged? yes 2.Did the red indicator move when the trigger was pressed?yes 3.Did the red indicator continue to move after the delivery stopped?yes 4.Were any cracking/popping sounds heard from the handle?not known 5.Was the stent partially exposed?no 6.If the stent was partially exposed, was it possible to recapture the stent fully before removal?na 6.Were any additional procedures needed?no.
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 (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending, a 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' "impossible to deploy stent" rep will arrange return."as per complaint form": stent would not deploy.Additional information received (b)(6) 2018: 1.Was the directional button fully engaged? yes 2.Did the red indicator move when the trigger was pressed?yes 3.Did the red indicator continue to move after the delivery stopped?yes 4.Were any cracking/popping sounds heard from the handle?not known 5.Was the stent partially exposed?no 6.If the stent was partially exposed, was it possible to recapture the stent fully before removal?na 6.Were any additional procedures needed?no.

• 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: 8252017
• Report Number: 3001845648-2019-00021
• Device Sequence Number: 1439762
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)190106(10)C1311877
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 02/13/2019

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: 01/06/2019
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1311877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018; 12/12/2018
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/13/2019; 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1