MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Ulceration (2116); No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Exact device details unknown, reported as a 10cm evolution fully covered stent.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

We then performed tandem stenting above the les.Then chose two fully covered evolution stents, 10 cm and 8 cm in length.The distal stent was placed first and the second, or overlapping, stent was then placed inside the first stent to hold the first stent in place, minimizing the risk of distal migration of both stents.Two days later, the patient was started on an oral diet after a contrast esophagogram revealed no evidence of a leak or fistula.The patient was discharged home.Due to patient¿s non-compliance, she was lost to follow-up until 12 months later.She denied any weight loss, abdominal pain, nausea or vomiting.During upper endoscopy, the esophageal fistula had completely healed with granulation tissues at the mid esophagus and a granulation polyp at the ge junction.The overlapping stents had migrated into the descending duodenum and were seen to be impacted just distal to the duodenal sweep.This is the pyloric channel.Considering the evolution stent has a strong closure lasso, we decided to remove the stent endoscopically.The gastroscope is then advanced inside the stent.Using an endoscopic grasping device, the closure lasso of the stent is first grasped, and then pulled, into the endoscopic channel.The proximal flange of the stent collapsed and the conjoint stents were removed easily.Both stents appeared to be intact on ex vivo examination.Within the duodenum, there are some stent-induced ulcerations and granulation tissue formation.

Manufacturer Narrative

This is a correction report to capture patient outcome from unknown to ''the patient outcome "patient¿s esophageal fistula was healed and migrated stents caused some stent-induced ulcerations and granulation tissue formation" as per cirl medical advisor input.

Event Description

We then performed tandem stenting above the les.Then chose two fully covered evolution stents, 10 cm and 8 cm in length.The distal stent was placed first and the second, or overlapping, stent was then placed inside the first stent to hold the first stent in place, minimizing the risk of distal migration of both stents.Two days later, the patient was started on an oral diet after a contrast esophagogram revealed no evidence of a leak or fistula.The patient was discharged home.Due to patient¿s non-compliance, she was lost to follow-up until 12 months later.She denied any weight loss, abdominal pain, nausea or vomiting.During upper endoscopy, the esophageal fistula had completely healed with granulation tissues at the mid esophagus and a granulation polyp at the ge junction.The overlapping stents had migrated into the descending duodenum and were seen to be impacted just distal to the duodenal sweep.This is the pyloric channel.Considering the evolution stent has a strong closure lasso, we decided to remove the stent endoscopically.The gastroscope is then advanced inside the stent.Using an endoscopic grasping device, the closure lasso of the stent is first grasped, and then pulled, into the endoscopic channel.The proximal flange of the stent collapsed and the conjoint stents were removed easily.Both stents appeared to be intact on ex vivo examination.Within the duodenum, there are some stent-induced ulcerations and granulation tissue formation.File is being updated to include patient outcomes of ''patient¿s esophageal fistula was healed and migrated stents caused some stent-induced ulcerations and granulation tissue formation" as per cirl medical advisor input.

Manufacturer Narrative

This file is related to pr 281929 and pr 282010.Device evaluation: the evo- fully-covered esophageal stent device of unknown lot number was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.Lab evaluation: n/a documents review including ifu review: as the evo (10cm evolution fully covered ) is listed as unknown device from unknown lot numbers, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo- (fully-covered esophageal stent) 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.As per the instructions for use, which informs the user about the potential complications "additional complications include, but are not limited to: stent misplacement and/or migration," on review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Image review: n/a root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, stent migration is listed as a complication following the placement of this device.Summary: customer complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

We then performed tandem stenting above the les.Then chose two fully covered evolution stents, 10 cm and 8 cm in length.The distal stent was placed first and the second, or overlapping, stent was then placed inside the first stent to hold the first stent in place, minimizing the risk of distal migration of both stents.Two days later, the patient was started on an oral diet after a contrast esophagogram revealed no evidence of a leak or fistula.The patient was discharged home.Due to patient¿s non-compliance, she was lost to follow-up until 12 months later.She denied any weight loss, abdominal pain, nausea or vomiting.During upper endoscopy, the esophageal fistula had completely healed with granulation tissues at the mid esophagus and a granulation polyp at the ge junction.The overlapping stents had migrated into the descending duodenum and were seen to be impacted just distal to the duodenal sweep.This is the pyloric channel.Considering the evolution stent has a strong closure lasso, we decided to remove the stent endoscopically.The gastroscope is then advanced inside the stent.Using an endoscopic grasping device, the closure lasso of the stent is first grasped, and then pulled, into the endoscopic channel.The proximal flange of the stent collapsed and the conjoint stents were removed easily.Both stents appeared to be intact on ex vivo examination.Within the duodenum, there are some stent-induced ulcerations and granulation tissue formation.

• Brand Name: UNKNOWN
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9314366
• MDR Text Key: 166324082
• Report Number: 3001845648-2019-00588
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 10/22/2019; 10/22/2019
• Supplement Dates FDA Received: 11/18/2019; 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention