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

Catalog Number EVO-FC-18-23-10-E

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Death (1802); Perforation (2001); Blood Loss (2597)

Event Date 02/25/2014

Event Type  Death  

Event Description

This report is being submitted in relation to a complaint event involving an evo-fc-18-23-10-e (evolution esophageal controlled-release stent - fully covered).This complaint report involved a patient death."a (b)(6) male patient had esophagus cancer.In (b)(6) 2013 (date unknown), the patient reported obstruction in the passage of food and esophageal cancer was diagnosed.The physician judged that the patient was not suitable for surgery.On (b)(6) 2013, fp-r started.On 10 days of illness during the first course of treatment, the patient had a fever and perforation of the esophagus was confirmed.With antibiotic administration, only radiation therapy was continued, but it was finished on a dose of 46gy.On 58 days of illness, ct and gf (gastro fiberscope) confirmed that primary lesion and lymph node were shrinking but esophago-mediastinal fistula remained.On (b)(6) 2013, evo-fc-18-23-10-e was implanted in the esophagus.On (b)(6) 2013, administration of ndp+5fu1c started.On (b)(6) 2013, dilation of the esophagus was performed.On (b)(6) 2013, administration of ndp+5fu2c started.On (b)(6) 2014, dilation of the esophagus was performed.On (b)(6) 2014, edema (it might have been saburra) was confirmed at lower end of the evolution.Therefore, another manufacturer's stent (nitis/ by century medical) was additionally placed with stent-in-stent technique.On (b)(6) 2014, administration of ndp+5fu3c started.On (b)(6) 2014, administration of ndp+sfu4c started.On (b)(6) 2014, no obvious stenosis was confirmed and chemotherapy was finished.At a later date, full expansion of the nitis stent due to improvement of the stenosis, stent shortening occurred.(the stent was eventually placed inside the evolution with 1cm of the nitis stent end out of the evolution end.Exact date of confirmation is unknown.) on (b)(6) 2014, emergency hospital admission was made due to hematemesis.The physician took a wait-and-see approach while the patient was hospitalized with food deprivation and fluid replacement.At 0:54 on (b)(6) 2014, the patient died due to hematemesis again which was not able to be controlled.Blood transfusion could not be in time.At a later date, autopsy was performed by pathologist and it confirmed perforation of esophagus and aorta.As of (b)(6) 2014, the physician is waiting for the result of autopsy.As of (b)(6) 2014, the date of autopsy cannot be confirmed.It may take several months to be able to receive the autopsy result." additional comments received from the physician as follows: "perforating site in the esophagus is likely to have met the place where the stent's lower end was positioned.However, because a pathologist took out the stents immediately after the autopsy, it cannot be determined which stent end (evolution or nitis) was positioned in there.I am waiting for the result of autopsy.It cannot be determined if radiation therapy contributed to the event.The cause of the hematemesis is perforation of the aorta by stent edge of either the evolution or nitis.It cannot be determined which evolution or nitis was related to the perforation.The cause of the death is perforation of the aorta.Stent edge perforated into the aorta.".

Manufacturer Narrative

There was no evo-fc-18-23-10-e device of lot c861577 in stock at the time of the investigation.The device was not available to be returned for evaluation.With the information provided a document based investigation was carried out autopsy photos were provided and were reviewed by the relevant personnel.A summary of these photos confirmed the evolution stent was completely intact.Bruising and fistula were evident in these photographs; however, as the pathologist had removed both stents prior to taking the photographs, stent positioning cannot be confirmed.Although requested images during/post stent placement have not been received.The complaint information was reviewed by the relevant personnel with the following feedback provided: clinically administering radiation therapy and placing stents is common and well known as therapy.However complications are related with perforation when placing stents in a wall that becomes thinner due to this therapy.Placing two stents in each other is increasing the radial force and could induce a perforation earlier then normally the instructions for use, ifu, advises the user in the precaution section as follows: "after stent placement alternative methods of treatment such as chemotherapy and radiation should not be administrated as this may increase risk of stent migration due to tumour shrinkage, stent erosion and/or mucosa bleeding." from the information provided chemotherapy was performed after stent placement.From the information provided,it may also be noted that prior to placing the evo stent it was confirmed (on 58 days of illness) that the primary lesion and lymph node were shrinking but an esophago-mediastinal fistula remained.However,, if the evo stent was placed to treat esophago-mediastinal fistula, this may be considered off label use.However, this has not yet been confirmed.As the instructions for use, ifu, this evo device is intended to be used to maintain patency of malignant oesophageal strictures and/or to seal tracheoesophageal fistulas." as the device and images have not been received, the cause of this complaint could not be conclusively determined.It cannot be determined from the autopsy photos or information provided which stent (evolution or nitis) was related to the perforation.As per the instructions fo use, ifu0061-4, perforation and haemorrhage are known potential complications associated with upper gl endoscopy.The customer complaint was confirmed based on customer testimony.Prior to distribution all evo-fc-18-23-10-e devices are subject to visual inspection and functional checks to ensure device integrity.A review of manufacturing records for evo-fc-18-23-10-e devices of lot c861577 and stent component did not reveal any discrepancies that could have contributed to the issue.From the information provided, on (b)(6) 2013, evo-fc-18-23-10-e was implanted in the esophagus and on (b)(6) 2014, another manufacturer's stent (nitis/ by century medical) was additionally placed with stent-in-stent technique.The patient died on (b)(6) 2014.The autopsy was performed by the pathologist and it confirmed perforation of esophagus and aorta.It may be noted as per the comment provided by the physician it cannot be determined which stent (evolution or nitis) was related to the perforation.It may take several months before an autopsy result is received.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan, unk ; 61334440
• MDR Report Key: 3946418
• MDR Text Key: 4644433
• Report Number: 3001845648-2014-00057
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2015
• Device Catalogue Number: EVO-FC-18-23-10-E
• Device Lot Number: C861577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/25/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 44 YR