MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Model Number G48030

Device Problems Kinked (1339); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # = k162717.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: "customer put device into the patient over a savary wire and the device would not deploy.Device pumped, but wouldn't deploy out of delivery system.It was in gear.Customer heard a pop sound, took device out and used a new one successfully." dm unsure regarding event date.

Manufacturer Narrative

Pma/510(k) # = k162717.(b)(4) importer.Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address:(b)(4).Importer site establishment registration number: (b)(4).Problem statement: ¿device wouldn't deploy out of delivery system¿ "customer put device into the patient over a wire and the device would not deploy.Device pumped, but wouldn't deploy out of delivery system.It was in gear.Customer heard a pop sound, took device out and used a new one successfully." device evaluation: the evo-20-25-8-e device of lot number c1306668 was not returned to cook ireland for evaluation.Additional information received: 1.Did any unintended section of the device remain inside the patient¿s body? no.2.Did the patient require any additional procedures due to this occurrence? no.3.Did the product cause or contribute to the need for additional procedures? no.4.Has the complainant reported any adverse effects on the patient due to this occurrence? no.5.Has the complainant reported that the product caused or contributed to the adverse effects? no.1.1.1 what is the reorder number of the wire guide used with this device? unknown, but probably--(b)(4).1.1.2 if not, with the device in question, how was the procedure finished? another device opened and used successfully.1.2 for complaints occurring during use (once in contact with patient) also ask: 1.2.1 what is the endoscope manufacturer and model number that was used during the procedure? olympus 190.1.2.2 had dilation of the stricture been performed prior to stent placement? no, not needed.1.2.3 what was the diameter of the stricture at the time of stent placement (in mm)? unknown.1.2.4 what was the length of the stricture at the time of stent placement (in cm)? unknown.1.2.5 please describe the location in the body where the stent was to be placed.Esophogus.1.2.6 was resistance encountered when advancing the wire guide through the stricture? no.1.2.7 was resistance encountered when advancing the introducer and stent into position? no.1.2.8 did any section of the device detach inside the patient? no.1.2.9 was the stent partially deployed when removed from the patient? no.1.2.10 after placement, was stent position verified? n/a didn't get that far.1.2.10.1 if yes, please describe how.1.2.11 after placement, was the endoscope advanced through the stent? n/a didn't get that far.1.2.12 please estimate amount of time the stent was in place prior to this occurrence.N/a didn't get that far.1.2.13 did the patient undergo chemotherapy or radiation treatments after stent placement? unknown.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Lab evaluation: as the device was not returned; a lab evaluation could not be conducted.Root cause: as the device was not returned at the time of the investigation and due to the lack of information provided, the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.Documents review: with the information provided a document based investigation was carried out.A review of the manufacturing records for evo-20-25-8-e of lot number c1306668 revealed no discrepancies that could have contributed to this complaint issue.Prior to distribution all evo-20-25-8-e 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.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: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Another device was used for deployment.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Reporting is based on the precedence of ¿flexor kinked/stretched/broke/compressed".As reported to customer relations: "customer put device into the patient over a savary wire and the device would not deploy.Device pumped, but wouldn't deploy out of delivery system.It was in gear.Customer heard a pop sound, took device out and used a new one successfully." dm unsure regarding event date.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7591701
• MDR Text Key: 111161455
• Report Number: 3001845648-2018-00269
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480305
• UDI-Public: (01)10827002480305(17)181216(10)C1306668
• 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: 06/12/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2018
• Device Model Number: G48030
• Device Catalogue Number: EVO-20-25-8-E
• Device Lot Number: C1306668
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1