Model Number 10390 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Endocarditis (1834)
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Event Date 04/19/2023 |
Event Type
Injury
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Event Description
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It was reported that infection occurred.A left atrial appendage (laa) closure procedure was performed and a 35mm watchman flx closure device was implanted.Approximately two (2) months post-implant at a routine follow-up, transesophageal echocardiogram (tee) was performed revealing filamentous strands.The patient was diagnosed with staph bacteremia.The physician is not certain what the cause is as the patient also has a valve replacement and pacemaker.
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Event Description
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It was reported that infection occurred.A left atrial appendage (laa) closure procedure was performed and a 35mm watchman flx closure device was implanted.Approximately two (2) months post-implant at a routine follow-up, transesophageal echocardiogram (tee) was performed revealing filamentous strands.The patient was diagnosed with staph bacteremia.The physician is not certain what the cause is as the patient also has a valve replacement and pacemaker.It was further reported that the patient underwent a lead extraction of the existing pacemaker and further review of the watchman closure device showed no more vegetation.There had been no shift or seal compromise of the watchman closure device.
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Manufacturer Narrative
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B5: additional information added.
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Manufacturer Narrative
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B3: updated from 4/29/2023 to 4/19/2023 to align with date of new information.B5: additional information added.H6: patient code added and evaluation conclusion code added.
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Event Description
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It was reported that infection occurred.A left atrial appendage (laa) closure procedure was performed and a 35mm watchman flx closure device was implanted.Approximately two (2) months post-implant at a routine follow-up, transesophageal echocardiogram (tee) was performed revealing filamentous strands.The patient was diagnosed with staph bacteremia.The physician is not certain what the cause is as the patient also has a valve replacement and pacemaker.It was further reported that the patient underwent a lead extraction of the existing pacemaker and further review of the watchman closure device showed no more vegetation.There had been no shift or seal compromise of the watchman closure device.It was further reported that the patient had endocarditis on (b)(6) 2023, 10 days prior to the routine follow up where the patient was diagnosed with staph bacteremia.
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Search Alerts/Recalls
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