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Model Number M00534350 |
Device Problems
Obstruction of Flow (2423); Device Stenosis (4066)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported to boston scientific corporation that an advanix biliary stent was used during a procedure, performed on (b)(6) 2022.During the procedure, it was noted that the stent was occluded.A blood clot was noticed in the stent.There was no information on what stent completed the procedure.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
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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's year of birth was 1953.Block h6: medical device problem code a1409 captures the reportable event of stent obstruction within device.Block h11: additional information block a3; a4 and b5 has been updated based on additional information received october 27, 2022.This event was reported by other health care professional.The physician is: dr.(b)(6).
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Event Description
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It was reported to boston scientific corporation that an advanix biliary stent was used during a procedure, performed on (b)(6) 2022.During the procedure, it was noted that the stent was occluded.A blood clot was noticed in the stent.There was no information on what stent completed the procedure.There were no patient complications reported as a result of this event.Additional information received on october 27, 2022: during a stent removal and placement procedure, the stent was deployed in the common bile duct, however, it was noted that the stent was occluded, and blood clot was noticed.The stent was removed using a snare and the procedure was successfully completed with another advanix biliary stent.It was reported that when the previous stent was removed via snare, there was a moderate amount of bleeding and then the new stent was put in which is how the stent was filled with the blood.There was nothing mentioned in the note about any additional treatments or interventions for the bleeding that happened during the procedure.
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Search Alerts/Recalls
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