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Model Number M00516730 |
Device Problem
Migration (4003)
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Patient Problems
Dysphagia/ Odynophagia (1815); Insufficient Information (4580)
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Event Date 03/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: the stent was explanted by dr.(b)(6).Block h6: imdrf patient code e2401 captures the reportable event of food impaction.Imdrf impact code f23 is being used to capture the additional intervention of removal of the migrated stent.Imdrf device code a010402 captures the reportable event of stent migration.
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Event Description
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It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the esophagus to treat a 5cm malignant stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement procedure.On (b)(6) 2022, the patient presented to the emergency department with food impaction.Upon checking, it was noted that the stent had completely migrated distally due to the stricture resolution.Subsequently, the stent was removed using graspers and the procedure was completed.
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Manufacturer Narrative
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Blocks b5 and h6 (patient code) have been updated with additional information received on march 01, 2024.Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: the stent was explanted by dr.(b)(6).Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf impact code f23 is being used to capture the additional intervention of removal of the migrated stent.Imdrf device code a010402 captures the reportable event of stent migration.
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Event Description
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It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the esophagus to treat a 5cm malignant stricture during an upper gastrointestinal (gi) endoscopy with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement procedure.On (b)(6) 2022, the patient presented to the emergency department with food impaction.Upon checking, it was noted that the stent had completely migrated distally due to the stricture resolution.Subsequently, the stent was removed using graspers and the procedure was completed.**additional information received on march 01, 2024** post-stent placement, the patient's dysphagia initially improved.However, the patient began to develop worsening dysphagia over time.
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Search Alerts/Recalls
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