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

Model Number G48030

Device Problems Positioning Failure (1158); Deformation Due to Compressive Stress (2889)

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

User checked there is a 1cm stenosis 24cm from incisor, and its surface appears stiffness.User implanted the stent per standard procedure, but patient coughed while the stent was released in desired position which cause the stent moved toward far end.User immediately pull the stent with forceps by gripping the white lasso at proximal -end of stent to reposition stent to desired area.After several attempts the stent was not moved a little and there was mild bleeding.User give up trying and left the stent in patient.Family of patient has great concerns and get emotional once aware the stent was not in the desired position to expand the stenosis.Patient outcome: the stent didn't expand the stenosis eventually and left in patient.And there is mild bleeding during attempt of reposition of stent.The family of patient has great concerns and get emotional once aware of the situation that the implanted stent is not in the right position to resolve the stenosis.

Event Description

Clinical input received 14aug2020: 1.Would you be able to suggest the cause of mild bleeding? the stent body during repositioning could cause trauma to mucosa and lead to mild bleeding.User checked there is a 1cm stenosis 24cm from incisor, and its surface appears stiffness.User implanted the stent per standard procedure, but patient coughed while the stent was released in desired position which cause the stent moved toward far end.User immediately pull the stent with forceps by gripping the white lasso at proximal -end of stent to reposition stent to desired area.After several attempts the stent was not moved a little and there was mild bleeding.User give up trying and left the stent in patient.Family of patient has great concerns and get emotional once aware the stent was not in the desired position to expand the stenosis.Patient outcome: the stent didn't expand the stenosis eventually and left in patient.And there is mild bleeding during attempt of reposition of stent.The family of patient has great concerns and get emotional once aware of the situation that the implanted stent is not in the right position to resolve the stenosis.

Manufacturer Narrative

510(k) number: k162717 clinical input received 14aug2020: 1.Would you be able to suggest the cause of mild bleeding? the stent body during repositioning could cause trauma to mucosa and lead to mild bleeding.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Image review was completed on 18jul2020, this supplement report is being submitted to capture this additional information.Also f6 "date user facility or importer became aware of event" has been corrected, the initial mdr submitted referenced the date the first cook employee was made aware (15jun2020), this has been amended to 01-jun-2020, the date the user facility became aware of the event.

Manufacturer Narrative

510(k) number: k162717.Image review was completed on 18jul2020.The date the first cook employee was made aware (15jun2020) was filled into f6 6.Date user facility or importer became aware of event in error on the initial mdr report, this has been amended to 01-jun-2020, the date when the event actually occurred.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

510(k) number: k162717.Device evaluation: the evo-20-25-8-e device of lot number c1647152 involved in this complaint device was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 14th july 2020.In summary the following results were observed in the lab evaluation: no visual defects were observed on the returned delivery system.No functional issues were reported with the delivery system, as per information provided ¿user implanted the stent per standard procedure¿, complaint is in relation to stent and white lasso which remain in the patient & therefore cannot be evaluated.Documents review including ifu review: prior to distribution all evo-20-25-8-e devices are subject to visual inspection and functional checks to ensure device integrity.There inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-20-25-8-e device of lot number c1647152 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot # c1647152; upon review of complaints this failure mode has not occurred previously with this lot # c1647152.As per the instructions for use, ifu0061-6 which accompanies this device instructs the user to "to reposition stent directly after placement, grip the white lasso at proximal-end of stent with forceps and reposition stent to desired area".There is no evidence to suggest that the customer did not follow the instructions for use.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression: the complaint of inability to grasp the white lasso loop cannot be confirmed.One photograph (figure 2) confirms that the blue line was grasped.It also most likely demonstrates the white lasso loop.This is consistent with the description of event statement that the white lasso was grasped and pulled upon.Inability to successful reposition the stent is confirmed.Superior repositioning was likely blocked by the tumor mound and possibly a pre-existing stent.Several attempts were made to identify if the 2nd stent was an evo stent, this could not be confirmed & there is no information to indicate that this was a cirl stent.Additional information was requested to confirm if the pre-existing stent was a cook stent.From additional provided: "customer responded the existed stent was implanted in patient at other hospital before but there is no information indicate what stent was implanted.No information can be found on the patient medical history." additional information requested from cook research inc.(cri) in relation to second stent, ¿unfortunately i am unable to get this information for you.You are going to need to reach out to shared services and have them reach out to the site to verify this information for you.Please let me know if you have any questions or concerns.' stent was misplaced, however, this was not a failure of the device as the ¿patient coughed while the stent was released in desired position which cause the stent moved toward far end.¿ as per imagine review: ¿it is unclear whether the cough occurred during release or afterwards.¿ as per ifu, ¿there is a lasso at the proximal end of the stent (partially covered) or the proximal and distal ends of the stent (fully covered), purpose is to reposition the stent in the event of incorrect placement.¿ however, user could not reposition stent after several attempts.Root cause review: a definitive root cause could not be determined from the limited available information.From the imaging review " superior repositioning was likely blocked by the tumor mound and possibly a pre-existing stent." summary: customer complaint is confirmed based on customer testimony.According to the initial reporter, the stent didn't expand the stenosis eventually and left in patient.And there is mild bleeding during attempt of reposition of stent.

Event Description

The investigation was concluded on the 09-oct-2020, this supplement report is being submitted to include the investigation conclusions within section h10.

• 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: 10268205
• MDR Text Key: 198691610
• Report Number: 3001845648-2020-00422
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480305
• UDI-Public: (01)10827002480305(17)210904(10)C1647152
• 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: 10/09/2020

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 Expiration Date: 09/04/2021
• Device Model Number: G48030
• Device Catalogue Number: EVO-20-25-8-E
• Device Lot Number: C1647152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/01/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 06/16/2020; 06/16/2020; 06/16/2020
• Supplement Dates FDA Received: 08/16/2020; 09/11/2020; 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR