MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S ESOPHAGEAL COVERED STENT; ESOPHAGEAL STENT

Model Number EST1810F

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Death (1802); Perforation (2001); Peritonitis (2252)

Event Date 01/30/2017

Event Type  Death  

Manufacturer Narrative

It was reported that actually, the placed stent was migrated until dumbbell-region but it was not found and not be treated at that time.After that, the patient dead due to peritonitis caused to perforation in duodenal bulb region.The surgeon commented that the stent had migrated forward to duodenal bulb by peristaltic motion, and the edge of stent might had given damage the wall of the gastrointestinal tract.It was successfully passed in the criteria of manufacturing and inspection as a result of confirmation of device history record for the relevant product.Migration can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.According to complaint product description, the placed stent was migrated until dumbbell-region but it was not found and not be treated at that time.It is, however, hard to find out exact root cause for this complaint because the suspected device was not returned and it is difficult to reconstruct the situation at the time of procedure with limited information.After the stent was implanted, the surgeon did not recognize that the stent migrated.So, stent was moved from cardia to duodenal bulb by peristaltic motion.It is considered that perforation was occurred because the migrated stent was result from complexity of patient's lesion status, peristalsis of organs, and drug use in general.The suspected device was not returned so it is difficult to judge perforation caused by device malfunction.We will continuously monitor the same or similar customer complaints through accurate analyses.

Event Description

(b)(6) 2017: est1810f was used for best supportive care (bsc) of stenosis due to gastric cardia cancer.(actually, a placed stent was migrated until dumbbell-region but it was not found and not be treated at that time).(b)(6) 2017: the patient visited the hospital and described symptoms that it felt the food get stuck, so ct was performed (not be performed an x[?]ray examination).(b)(6) 2017: 18:00pm: a stomachache happened; 21:59pm: the patient was taken to the hospital emergently.The blood pressure was 60 and he was in shock state.Since he had treated as bsc and his general status was very bad, the surgeon decided to not be applied to the operation and a morphine was given as pain relief.(b)(6) 2017: 22:00pm: the patient dead.The cause of death: peritonitis due to perforation in duodenal bulb region.The surgeon's comments the stent had migrated forward to duodenal bulb by peristaltic motion.In the meantime, the edge of stent might had given damage the wall of the gastrointestinal tract, so that result in perforation.Then it also might had been caused to gastrointestinal hemorrhage and shock state for the patient.He also commented that he should have selected the stent which is hard to migrate by peristaltic motion, for placing at cardia region.

• Brand Name: NITI-S ESOPHAGEAL COVERED STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer (Section G): TAEWOONG MEDICAL CO.,LTD.; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022 ; KS 10022
• Manufacturer Contact: park ; 14, gojeong-ro; wolgot-myeon; gimpo-si, gyeonggi-do 10022
• MDR Report Key: 6878236
• MDR Text Key: 86690093
• Report Number: 3003902943-2017-00032
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2017

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: 07/03/2019
• Device Model Number: EST1810F
• Device Catalogue Number: TW-TC-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2016
• 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: 89 YR