MAUDE Adverse Event Report: COOK IRELAND LTD COTTON-LEUNG BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G21684
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the customer reported the following complaint issue; "they were able to confirm the stent migration immediately after placement of the stent.So they removed migration stent." the clso-7-8 device was expected to be returned for a lab evaluation; however as of 21/jun/2017 the device has not been returned.The complaint investigation will be updated with lab evaluation findings once the device is returned.As the device involved in this complaint was not returned for an evaluation, it was not possible to determine a definitive root cause for the customer complaint.However, it should be noted that the stent was used passed the expiration date and in the absence of testing the device beyond its shelf life, we cannot support its functionality once it is expired.So on that basis, it is possible that the using a device that is expired may impact its functionality and may have contributed to this event.It should also be noted that the stent contains flaps to prevent migration.Since this migration event occurred during withdrawal of the introduction system, the most probable root cause of this customer complaint could be attributed to incorrect size selection (both too short or too long for the stricture could cause migration), or to incorrect placement of the stent across the stricture which could also lead to stent migration.It is also possible that the user used an incorrect method to place the stent or to remove the introducer components.The customer complaint was confirmed based on customer testimony.As per instructions for use, ifu0045-6: ¿this device is used to drain obstructed biliary ducts¿.As per a precaution included in the instructions for use for this device: ¿the tapered tip end of the stent* or side holes* must be positioned in the common bile duct while the other end remains in the duodenum.The longer flaps of the st-2 biliary stent should be positioned in the duct while the shorter flaps remain in the duodenum.¿ it may be noted that stent migration is stated as a potential complication associated with the placement of clso devices in the ifu (ifu0045-6).There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc it should be noted that the clso-7-8 device involved in this complaint was manufactured on 06/may/2014 and has an expiry of may 2017 as per the product label, the migration event involved stent placement and immediate migration on 13/jun/ 2017 which means this device was used after the expiration date contrary to the product labelling.Prior to distribution, all clso-7-8 devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Complaints of this nature will continue to be monitored for potential emerging trends.H3 other text : 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: ed sutkowski cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195 importer site establishment registration number: 3005580113 the customer reported the following complaint issue; "they were able to confirm the stent migration immediately after placement of the stent.So they removed migration stent." the clso-7-8 device was expected to be returned for a lab evaluation; however as of 21/jun/2017 the device has not been returned.The complaint investigation will be updated with lab evaluation findings once the device is returned.As the device involved in this complaint was not returned for an evaluation, it was not possible to determine a definitive root cause for the customer complaint.However, it should be noted that the stent was used passed the expiration date and in the absence of testing the device beyond its shelf life, we cannot support its functionality once it is expired.So on that basis, it is possible that the using a device that is expired may impact its functionality and may have contributed to this event.It should also be noted that the stent contains flaps to prevent migration.Since this migration event occurred during withdrawal of the introduction system, the most probable root cause of this customer complaint could be attributed to incorrect size selection (both too short or too long for the stricture could cause migration), or to incorrect placement of the stent across the stricture which could also lead to stent migration.It is also possible that the user used an incorrect method to place the stent or to remove the introducer components.The customer complaint was confirmed based on customer testimony.As per instructions for use, ifu0045-6: ¿this device is used to drain obstructed biliary ducts¿.As per a precaution included in the instructions for use for this device: ¿the tapered tip end of the stent* or side holes* must be positioned in the common bile duct while the other end remains in the duodenum.The longer flaps of the st-2 biliary stent should be positioned in the duct while the shorter flaps remain in the duodenum.¿ it may be noted that stent migration is stated as a potential complication associated with the placement of clso devices in the ifu (ifu0045-6).There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc it should be noted that the clso-7-8 device involved in this complaint was manufactured on 06/may/2014 and has an expiry of may 2017 as per the product label, the migration event involved stent placement and immediate migration on 13/jun/ 2017 which means this device was used after the expiration date contrary to the product labelling.Prior to distribution, all clso-7-8 devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
They were able to confirm the stent migration immediately after placement of the stent.So they removed migration stent.
Additional Manufacturer Narrative
Cook (b)(4) ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.(b)(4).Importer site establishment registration number: (b)(4).The clso-7-8 device was returned for a lab evaluation.A lab evaluation was held on 13july2017.During the lab evaluation it was noted that there was damage at duodenal and ductal ends of the stent which are consistent with stent removal.The anti- migration features ( flaps) were inspected and found to be as expected.There were no other defects observed on the stent that could have contributed to the complaint event.It should be noted that the stent was used passed the expiration date and in the absence of testing the device beyond its shelf life, we cannot support its functionality once it is expired.So on that basis, it is possible that the using a device that is expired may impact its functionality and may have contributed to this event.It should also be noted that the stent contains flaps to prevent migration.Since this migration event occurred during withdrawal of the introduction system, the most probable root cause of this customer complaint could be attributed to incorrect size selection (both too short or too long for the stricture could cause migration), or to incorrect placement of the stent across the stricture which could also lead to stent migration.It is also possible that the user used an incorrect method to place the stent or to remove the introducer components.The customer complaint was confirmed based on customer testimony.As per instructions for use, ifu0045-6: ¿this device is used to drain obstructed biliary ducts¿.As per a precaution included in the instructions for use for this device: ¿the tapered tip end of the stent* or side holes* must be positioned in the common bile duct while the other end remains in the duodenum.The longer flaps of the st-2 biliary stent should be positioned in the duct while the shorter flaps remain in the duodenum.¿ it may be noted that stent migration is stated as a potential complication associated with the placement of clso devices in the ifu (ifu0045-6).It should be noted that the clso-7-8 device involved in this complaint was manufactured on 06/may/2014 and has an expiry of may 2017 as per the product label, the migration event involved stent placement and immediate migration on 13/jun/ 2017 which means this device was used after the expiration date contrary to the product labelling.Prior to distribution, all clso-7-8 devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up is being submitted as the device was returned and evaluated they were able to confirm the stent migration immediately after placement of the stent.So they removed migration stent.

• Brand Name: COTTON-LEUNG BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6705086
• Report Number: 3001845648-2017-00266
• Device Sequence Number: 1570433
• Product Code: FGE
• UDI-Device Identifier: 00827002216846
• UDI-Public: (01)00827002216846(17)170506(10)C997803
• Combination Product (Y/N): N
• PMA/510(K) Number: K851962
• 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,Followup
• Report Date (Section B): 07/13/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: G21684
• Device Catalogue Number: CLSO-7-8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention