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Model Number M00516730 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex esophageal fully covered stent was implanted to treat a 2 cm benign refractory esophageal stricture during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.On (b)(6) 2021, during a routine follow-up, an esophagogastroduodenoscopy (egd) procedure was performed and it was noted that a patch of about six cells on the stent cover were damaged.Reportedly, the stent was removed from the patient and the procedure was completed.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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