MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; FAD STENT, URETERAL

Catalog Number EVO-22-27-6-D

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation (2001)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 evo-22-27-6-d was placed in pre-existing century medical's niti-s stent.(stent-in-stent).The sales.Rep visited the hospital twice after the procedure (one week later and two weeks later) and the patient had no problems.Then, the patient was discharged the hospital.On (b)(6) 2019 the patient hit the abdomen hard and the patient was hospitalized.Free air was confirmed with x-ray image.The cause of the free air is unknown so far.The patient condition has been stable for now.Endoscopy will be performed.

Manufacturer Narrative

510(k) number: k163468.Device evaluation: the device involved in this complaint was not returned to cirl for evaluation.With the information provided, a document based investigation will be complete.Lab evaluation: n/a.Image review: n/a.Document review including ifu review: prior to distribution all evo-22-27-6-d 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 the evo-22-27-6-d device could not be complete as the lot number is unknown.As per instructions for us, which accompanies this device: perforation & intestinal perforation are listed as potential complications.There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed the patient hitting his/her abdomen hard as reported.Summary: complaint is confirmed based on the customers testimony.According to the initial reporter, the patient condition has been stable for now.Endoscopy will be performed.An update on the patient condition has been requested but has not been provided.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

On (b)(6) 2019, evo-22-27-6-d was placed in pre-exsiting century medical's niti-s stent.(stent-in-stent).The sales rep visited the hospital twice after the procedure (one week later and two weeks later) and the patient had no problems.Then, the patient was discharged the hospital.On (b)(6) 2019, the patient hit the abdomen hard and the patient was hospitalized.Free air was confirmed with x-ray image.The cause of the free air is unknown so far.The patient condition has been stable for now.Endoscopy will be performed.

Event Description

On (b)(6) 2019 evo-22-27-6-d was placed in pre-existing century medical's niti-s stent.(stent-in-stent).The sales rep visited the hospital twice after the procedure(one week later and two weeks later) and the patient had no problems.Then, the patient was discharged the hospital.On (b)(6) 2019 the patient hit the abdomen hard and the patient was hospitalized.Free air was confirmed with x-ray image.The cause of the free air is unknown so far.The patient condition has been stable for now.Endoscopy will be performed.[(b)(6) 2019 (b)(6) ] additional information provided.Patient death reported.According to the sales rep,date of the death, reason of the death, series of event until the patient death are all unknown.According to the customer, further information will not be provided.Clinical input from cook ireland medical advisor for this complaint received on 18-nov-2019 as follows: "there was a cook stent involved in this complaint, however the patient¿s death was not directly related to cook stent.As per user¿s comments, the patient hit his/her abdomen hard which would have been a main reason of the perforation and the user didn¿t think the patient death was caused by the stent.Cook stent was deployed inside a pre-exsiting century medical's niti-s stent, which might contribute to the rigidness of niti-s stent, however, the perforation was due to the hard hit in the abdomen which eventually led to patient¿s, therefore, the patient¿s death was not directly related to cook stent.".

Manufacturer Narrative

K163468 - us clearance number.Device evaluation: the device involved in this complaint was not returned to cirl for evaluation.With the information provided, a document based investigation will be complete.Lab evaluation: n/a.Image review: n/a.Document review including ifu review: prior to distribution all evo-22-27-6-d 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 the evo-22-27-6-d device could not be complete as the lot number is unknown.As per instructions for use ifu0053-9 which accompanies this device: perforation & intestinal perforation are listed as potential complications.There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed the patient hitting his/her abdomen hard as reported.As per medical advisor "there was a cook stent involved in this complaint, however the patient¿s death was not directly related to cook stent.As per user¿s comments, the patient hit his/her abdomen hard which would have been a main reason of the perforation and the user didn¿t think the patient death was caused by the stent.Cook stent was deployed inside a pre-existing century medical's niti-s stent, which might contribute to the rigidness of niti-s stent, however, the perforation was due to the hard hit in the abdomen which eventually led to patient¿s, therefore, the patient¿s death was not directly related to cook stent.Summary: complaint is confirmed based on the customers testimony.According to the initial reporter, the patient death was reported.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

This follow up report is being submitted based on additional information received confirming patient death on (b)(6) 2019.Investigation into the cause of the reported patient death is ongoing.

Event Description

This follow up report is being submitted based on additional information received confirming patient death on (b)(6) 2019.Investigation into the cause of the reported patient death is ongoing.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8964901
• MDR Text Key: 161204072
• Report Number: 3001845648-2019-00451
• Device Sequence Number: 1
• Product Code: FAD
• 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
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO-22-27-6-D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/08/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 08/09/2019; 08/09/2019; 08/09/2019
• Supplement Dates FDA Received: 10/03/2019; 11/07/2019; 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention