|
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
|
Patient Problems
Abdominal Pain (1685); Chest Pain (1776); Nausea (1970); Vomiting (2144)
|
Event Date 12/07/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Block a2: patient's weight: 143.3 lb.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of stent migration.
|
|
Event Description
|
It was reported to boston scientific corporation that a wallflex fully covered esophageal stent was implanted in the esophagus to treat a stricture during a stent placement procedure performed on an unknown date.The patient's anatomy was not dilated prior to stent placement.During follow up, the stent was found to have migrated.On (b)(6) 2023, endoscopy was done, and stent fixation was performed using xtack.On (b)(6) 2023, stent removal was performed.The patient experienced minimal chest pain, abdominal pain, nausea and vomiting.Patient complications were resolved.
|
|
Manufacturer Narrative
|
Block a2: patient's weight: 143.3 lb.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h11: blocks b5, b7, d6a (implant date), and h6 (device and impact codes) have been corrected following a review which determined that the stent did not migrate, and an additional device was not required.
|
|
Event Description
|
It was reported to boston scientific corporation that a wallflex fully covered esophageal stent along with an xtack was implanted in the esophagus to treat a stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not dilated prior to stent placement.During follow up, the stent was found to have migrated.On (b)(6) 2023, endoscopy was done, xtack was not visible and the intended therapeutic dwell time was reached.On (b)(6) 2023, stent removal was performed.The patient experienced minimal chest pain, abdominal pain, nausea and vomiting.Patient complications were resolved.
|
|
Search Alerts/Recalls
|
|
|