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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # = 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.Problem statement: snap audible sound heard from the device while deploying the stent.Upon reaching the point of no return while deploying the stent, dr (b)(6) said that there was snap audible sound from the device, in fear of the stent may cause further complication, dr (b)(6) asked the nurse to recapture the whole stent into the device.And according him, there was no any difficulty in taking out the device out from the patient.The case was then completed by using a tae-woong stent and case was reported to be successful.Device evaluation: the evo-25-30-8-c device of lot number c1261846 was returned to cook ireland and evaluated on the 11-july-2018.The following additional information was also received in the complaint file: general questions: what endoscope type and channel size was used? colonoscope, 3.7mm.What was the position of the elevator? was it opened or closed? open.Details of the wire guide used (diameter, type, make)? 0.035 inch, visiglide, olympus.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes, mid colon region.Stricture information: what was the length and diameter of the stricture? 3cm.Where was the stricture located in the body? colon.Was there resistance felt passing wire guide through stricture? no.Was there resistance felt passing the evolution through stricture? yes.Was the stricture dilated before stent placement? yes.Questions related to during insertion into patient: was the product inspected for kinks or damage before use? yes.Was resistance felt during insertion into patient? if yes, at what point? yes, right at the point-of-no-return.Questions related to during stent placement: was the yellow marker kept in view during deployment? yes, about 4-5cm away from the stricture.Lab evaluation: upon evaluation of the returned device, there was a kink at the handle most likely due to transportation of the device.Handle was dismantled and it was evident that the flexor was broken at the shuttle cap.The stent was manually deployed with no issues observed with the stent.When the trigger was activated there was no deployment or recapture of the stent.The red indicator did move showing the handle mechanism was working but flexor no longer connected.Red cursor at the proximal end of handle indicating stent should be deployed.Flexor is in fully recaptured position with stent partially deployed approx.1 cm.Lock wire not returned.Customer complaint confirmed as failure was verified in laboratory.The flexor was seen to be broken during the lab evaluation.Root cause: it¿s likely the potential cause of failure is related to handling damage which damaged/weakened/kinked the wall of the flexor.This resulted in a build up of pressure and the flexor breaking during the procedure.Document review: prior to distribution all evo-25-30-6-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 qc records showed a nc (flexor delamination) was noted on the work order, however this was subsequently re- worked and would not have attributed to this complaint issue.Ifu review: as per the instructions for use, 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".On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Summary: customer complaint confirmed as failure was verified in laboratory.The flexor was seen to be broken during the lab evaluation.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.
Event or Problem Description
Report is being submitted under the precedence of "flexor kinked/stretched/broken/compressed" and "stent removed while partially exposed".Upon reaching the point of no return while deploying the stent, dr (b)(6) said that there was snap audible sound from the device, in fear of the stent may cause further complication, dr (b)(6) asked the nurse to recapture the whole stent into the device.And "according to" him, there was no any difficulty in taking out the device out from the patient.The case was then completed by using a tae-woong stent and case was reported to be successful.

• 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: 7718350
• Report Number: 3001845648-2018-00343
• Device Sequence Number: 1065121
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)180816(10)C1261846
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 07/25/2018

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: 08/16/2018
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1261846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1