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

Model Number G52226

Device Problems Off-Label Use (1494); Activation, Positioning or Separation Problem (2906)

Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complaint called in by dm on 06jan2020--did 07jan2020.As reported to customer relations: "while placing esophageal stent, the wire was in place.When the physician went to place the stent over the wire, there was visible resistance; dm, watching under fluoro, saw that stent was not moving down/advancing over the wire.Physician was having difficulty pushing stent over wire in the patient's mouth.Dm told physician to hold, and possibly change patient position, since stent was not visible under fluoro.Dm had them stop and pull it back out of patient's mouth; physician determined that the wire was the issue at this point.Physician pulled stent out, off of the wire, and all could see that wire was bent in 3 places (b)(4).Physician asked for another wire.Physician pulled original wire out, put scope down patient, and they could see bleeding that was not noticed by dm prior to the resistance event.Dm mentioned not noticing any stricturing, physician advanced the new wire through the scope, dm asked if they could do a couple trigger pulls themselves, to simulate recapturing to make sure it worked okay--it did deploy and recapture smoothly.However, the stent was visibly kinked inside of catheter (b)(4).Catheter was also kinked in multiple places.Physician tried to put kinked stent over the new wire and there was too much resistance.Physician asked for another stent, pulled defective stent off.Grabbed a 10cm stent and advanced it over 2nd wire.Dm, watching under fluoro, saw it come down smoothly and normally.Dm saw physician had patient's head tilted and said it helps to "jostle" it a bit.Physician got 2nd stent in position and deployed perfectly with no issues.Inner catheter was removed, and the 2nd stent remains in the patient.This procedure was for a benign condition called persistent anastomotic leak.Because of that, generally a hemoclip would be put around the tissue in the top proximal flange of the stent to hold it in position.Physician asked for a clip.Scope was down in position and physician made comment that the patient's throat had a small tear and they would have to stitch it up.Went to place the first clip, it deployed fine.Went to place a 2nd clip, the tech pre-deployed it (b)(4); physician had to go in and retrieve it (retrieved successfully after multiple attempts).Physician called that portion of procedure over at that point.Physician asked for suturing devices, needles and threads to sew up tear in patient's throat.When procedure was over, physician remarked that it helps not to force the stent.Dm asked if the physician believed forcing the stent caused the tear, physician affirmed that they believed it did.Physician's original intent (prior to procedure) was to leave stent in for 6 weeks, but because of placement and tear, he is not sure what he's going to do.Physician tried to see if leak was covered by stent after procedure (under x-ray); it was hard to get a conclusive image to indicate whether it was covered or not.When physician was asked by dm about their follow-up, if they would place another stent or something else, they were not sure what they would do next because of the tear and because the stent that had already been placed was place "pretty high." 1st wire: g57281 (lot # ); 2nd wire: g57280 (lot # w4293385); 1st stent: g52226 (lot # ); 2nd stent: g52227 (lot # c1653721).Olympus scope, dm believes it was upper egd scope.Position of patient was laying on their back with a semi-flat pillow under their head.Unknown hemoclip (tech's first time attempting to use a clip, dm showed tech how to do it again after procedure).Tip of the flange on the 2nd stent was measured at 23cm.No kinks visible on either wire guide prior to insertion in patient, both had just been opened for that procedure.

Manufacturer Narrative

Pma/510(k)#: k162717.This file is related to (b)(4) raised by cook endoscopy.Additional complaint file pr296395 was raised to capture off label use for the second stent.Device evaluation: the evo-fc-20-25-12-e device of lot number c1660564 was unavailable for evaluation.With the information provided, document based investigation was conducted.Lab evaluation: documents review including ifu reviev.Prior to distribution all evo-fc-20-25-12-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-fc-20-25-12-e device of lot number c1660564 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 #c1660564 ; upon review of complaints this failure mode has not occurred previously with this lot #c1660564.The instructions for use (b)(4) instructs the user to" this device is used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal".Also instructs the user about equipment required: "the stent is mounted on an inner catheter, which accepts a.035 inch wire guide, and is constrained by an outer catheter." there is evidence to suggest that the customer did not follow the instructions for use.From the information provided this procedure was for a benign condition called persistent anastomotic leak.However this device is used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal.Regarding the wire guide, the sgw was used and this wire is only intended to introduce the sgd ¿ savary-gilliard dilators so this is off label , however, this device accepts 0.035 inch wire guide (equipment required) root cause review: a definitive root cause could be determined from the available information.From the information provided it is known that the user used the device off-label, as the stent for malignant indication was used for benign indication, this would be off-label use.Also the stent was used with the sgw wire guide, which is only intended to introduce the sgd ¿ savary-gilliard dilators and we also know that the wire was bent in 3 places, attempting to advance the evo device over this wireguide for an unintended indication a combination of both could have caused advancement difficulties and subsequently led to damage of the device.Summary: complaint is confirmed based on the customer's testimony.According to the information reported, there have been tear in throat (subsequently stitched) reported.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Complaint called in by dm on 06jan2020--did 07jan2020.As reported to customer relations: "while placing esophageal stent, the wire was in place.When the physician went to place the stent over the wire, there was visible resistance; dm, watching under fluoro, saw that stent was not moving down/advancing over the wire.Physician was having difficulty pushing stent over wire in the patient's mouth.Dm told physician to hold, and possibly change patient position, since stent was not visible under fluoro.Dm had them stop and pull it back out of patient's mouth; physician determined that the wire was the issue at this point.Physician pulled stent out, off of the wire, and all could see that wire was bent in 3 places (b)(4).Physician asked for another wire.Physician pulled original wire out, put scope down patient, and they could see bleeding that was not noticed by dm prior to the resistance event.Dm mentioned not noticing any stricturing, physician advanced the new wire through the scope, dm asked if they could do a couple trigger pulls themselves, to simulate recapturing to make sure it worked okay--it did deploy and recapture smoothly.However, the stent was visibly kinked inside of catheter (pr289107).Catheter was also kinked in multiple places.Physician tried to put kinked stent over the new wire and there was too much resistance.Physician asked for another stent, pulled defective stent off.Grabbed a 10cm stent and advanced it over 2nd wire.Dm, watching under fluoro, saw it come down smoothly and normally.Dm saw physician had patient's head tilted and said it helps to "jostle" it a bit.Physician got 2nd stent in position and deployed perfectly with no issues.Inner catheter was removed, and the 2nd stent remains in the patient.This procedure was for a benign condition called persistent anastomotic leak.Because of that, generally a hemoclip would be put around the tissue in the top proximal flange of the stent to hold it in position.Physician asked for a clip.Scope was down in position and physician made comment that the patient's throat had a small tear and they would have to stitch it up.Went to place the first clip, it deployed fine.Went to place a 2nd clip, the tech pre-deployed it (b)(4); physician had to go in and retrieve it (retrieved successfully after multiple attempts).Physician called that portion of procedure over at that point.Physician asked for suturing devices, needles and threads to sew up tear in patient's throat.When procedure was over, physician remarked that it helps not to force the stent.Dm asked if the physician believed forcing the stent caused the tear, physician affirmed that they believed it did.Physician's original intent (prior to procedure) was to leave stent in for 6 weeks, but because of placement and tear, he is not sure what he's going to do.Physician tried to see if leak was covered by stent after procedure (under x-ray); it was hard to get a conclusive image to indicate whether it was covered or not.When physician was asked by dm about their follow-up, if they would place another stent or something else, they were not sure what they would do next because of the tear and because the stent that had already been placed was place "pretty high." 1st wire: g57281 (lot # ).2nd wire: g57280 (lot # w4293385).1st stent: g52226 (lot # ).2nd stent: g52227 (lot # c1653721).Olympus scope, dm believes it was upper egd scope.Position of patient was laying on their back with a semi-flat pillow under their head.Notes: unknown hemoclip (tech's first time attempting to use a clip, dm showed tech how to do it again after procedure) tip of the flange on the 2nd stent was measured at 23cm.No kinks visible on either wire guide prior to insertion in patient, both had just been opened for thtat procedure.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9659973
• MDR Text Key: 191198708
• Report Number: 3001845648-2020-00073
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002522265
• UDI-Public: (01)10827002522265(17)211017(10)C1660564
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• 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: 03/26/2020

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: 10/17/2021
• Device Model Number: G52226
• Device Catalogue Number: EVO-FC-20-25-12-E
• Device Lot Number: C1660564
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention