MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48027

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

The 510(k) number: k163468.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include investigation conclusions.

Event Description

This file is being reported based on the fda mdr malfunction precedence "stent fracture" the exact lot number is not known he will inform of this later.The product was used today and the stent broke."as per complaint form": during a controlling, the new stent after 4 weeks, the physician find a disintegrated stent, in the original position.At least on 4 positons was the stent broken.

Event Description

This file is being reported based on the fda mdr malfunction precedence "stent fracture".The exact lot number is not known he will inform of this later.The product was used today and the stent broke."as per complaint form": during a controlling, the new stent after 4 weeks, the physician find a disentegrated stent, in the original position.At least on 4 postions was the stent brocken.

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 mfr site as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

This file is being reported based on the fda mdr malfunction precedence "stent fracture".The exact lot number is not known he will inform of this later.The product was used today and the stent broke."as per complaint form": during a controlling, the new stent after 4 weeks, the physician find a disintegrated stent, in the original position.At least on 4 positons was the stent broken.

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)(6).(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.

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).As per customer testimony "the patient left the hospital after implantation.Weeks later, the doctor had not heard anything from the patient.Now the doctor has left the hospital also." the evo-22-27-12-d device of lot number c1510524 was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.Prior to distribution all evo-22-27-12-d devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Upon review of complaints, this failure mode has not occurred previously with the lot number c1510524.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1510524.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.A definitive root cause could not be determined from the available information.However a possible root cause could be attributed that due to a combination of stomach acid and repeated mechanical forces leading to fatigue of the wire.Customer complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up is being submitted as additional information was received.This file is being reported based on the fda mdr malfunction precedence "stent fracture" the exact lot number is not known he will inform of this later.The product was used today and the stent broke."as per complaint form": during a controlling, the new stent after 4 weeks, the physician find a disentegrated stent, in the original position.At least on 4 postions was the stent brocken.

Event Description

This file is being reported based on the fda mdr malfunction precedence "stent fracture." the exact lot number is not known he will inform of this later.The product was used today and the stent broke."as per complaint form": during a controlling, the new stent after 4 weeks, the physician find a disintegrated stent, in the original position.At least on 4 positons was the stent broken.

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)(6).Cook medical incorporated (cmi) 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).Lab evaluation: the evo-22-27-12-d device of lot number c1510524 was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.Documents review including ifu review: prior to distribution all evo-22-27-12-d devices are subject to 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-22-27-12-d device of lot number c1510524 did not reveal any issues which could have contributed to this complaint issue.Upon review of complaints, this failure mode has not occurred previously with the lot number c1510524.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1510524.As per the instructions for use, ifu0053-9, 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.Root cause review: a definitive root cause could not be determined from the available information.However a possible root cause could be attributed that due to a combination of stomach acid and repeated mechanical forces leading to fatigue of the wire.Summary: customer complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

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 Description

The exact lot number is not known he will inform of this later.The product was used today and the stent broke."as per complaint form": during a controlling, the new stent after 4 weeks, the physician find a disintegrated stent, in the original position.At least on 4 positons was the stent broken.".

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7922333
• MDR Text Key: 123677344
• Report Number: 3001845648-2018-00458
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)200614(10)C1510524
• 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,Followup,Followup,Followup
• Report Date: 01/16/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1510524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 09/03/2018; 09/03/2018; 09/03/2018; 09/03/2018; 09/03/2018
• Supplement Dates FDA Received: 10/25/2018; 11/23/2018; 12/19/2018; 01/16/2019; 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1