Model Number M00516750 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/16/2023 |
Event Type
Death
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Manufacturer Narrative
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Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf impact code f02 captures the reportable event of death.
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Event Description
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Note: this report pertains to one of two devices used on the same patient.Refer to manufacturer report # 3005099803-2023-06992 for the associated device information.It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted during a stent placement procedure performed on (b)(6)2023.On (b)(6) 2023, a second wallflex esophageal fully covered stent was implanted to reinforce the closure of the fistula.On an unknown date, post-stent placement of the second wallflex esophageal stent, the patient passed away.The relationship between the wallflex esophageal stents and the patient's death is unknown.
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Manufacturer Narrative
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Blocks b2 (date of death), b3, and b5 have been updated with additional information received on january 14, 2024.Block h6: imdrf impact code f02 captures the reportable event of death.
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Event Description
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Note: this report pertains to one of two devices used on the same patient.Refer to manufacturer report#: 3005099803-2023-06992 and 3005099803-2023-06993 for the associated device information.It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted during a stent placement procedure performed on (b)(6) 2023.On (b)(6) 2023, a second wallflex esophageal fully covered stent was implanted to reinforce the closure of the fistula.On an unknown date, post-stent placement of the second wallflex esophageal stent, the patient passed away.The relationship between the wallflex esophageal stents and the patient's death is unknown.Additional information received on january 14, 2024.The patient passed away on (b)(6) 2023.
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Manufacturer Narrative
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Block h6: imdrf impact code f02 captures the reportable event of death.Block h11: block b5 has been corrected.
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Event Description
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Note: this report pertains to one of two devices used on the same patient.Refer to manufacturer report#: 3005099803-2023-06992 and 3005099803-2023-06993 for the associated device information.It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted during a stent placement procedure performed on (b)(6) 2023.On (b)(6) 2023, a second wallflex esophageal fully covered stent was implanted to reinforce the closure of the fistula.On an unknown date, post-stent placement of the second wallflex esophageal stent, the patient passed away.The relationship between the wallflex esophageal stents and the patient's death is unknown.Additional information received on january 14, 2024.The patient passed away on (b)(6) 2023.Update based on review on january 31, 2024.The first wallflex esophageal stent was partially covered.
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Search Alerts/Recalls
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