Catalog Number MAXX-2312/C |
Device Problems
Fracture (1260); Material Separation (1562)
|
Patient Problem
Abrasion (1689)
|
Event Date 03/12/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
|
|
Event Description
|
The account alleges that during a follow-up appointment, the physician noted that the stent had migrated into the patient's stomach.This was verified via flexible scope images.The stent was placed on (b)(6) 2017 for malignant esophageal cancer.No difficulties were noted during stent placement.The patient had been undergoing radiation treatment post-stent placement.The physician tried to remove the stent with a pair of "rat tooth" forceps but was unsuccessful.A snare was then used to successfully remove the stent from the patient.During retrieval, some minor abrasions and esophageal bleeding was noted.No serious injury to report.A new stent will be placed in the near future.
|
|
Manufacturer Narrative
|
The suspect device was returned for evaluation.The device was examined visually.The complaint of migration could not be confirmed, however, the returned device was found to be torn.The root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.
|
|
Search Alerts/Recalls
|