Model Number 9-VSDMUSCPI-018 |
Device Problem
Missing Information (4053)
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Patient Problem
Death (1802)
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Event Date 03/18/2019 |
Event Type
Death
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Event Description
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On (b)(6) 2019, a 18mm vsd musc pi occluder and 20mm vsd music pi occluder was selected for closure of a muscular vsd.During placement, of the 20mm vsd musc pi occluder, the patient became unstable and resuscitation was attempted without success.Additional information has been requested.
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Manufacturer Narrative
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An unspecified issue and patient death was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported incident could not be conclusively determined; however, per the site the patient was very unstable due to post infarct vsd.
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Event Description
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Three weeks prior to this event's procedure, the patient experienced myocardial infarction.On (b)(6) 2019, the patient was very unstable due to the post infarct ventricular septal defect (pi vsd), so a 18mm amplatzer p.I.Muscular vsd occluder (pi mvso) and 20mm pi mvso were selected for use to occlude the pi vsd.The 18mm pi mvso was deployed but resheathed for upsizing.During placement of the 20mm pi mvso, the patient's unstable condition worsened, and resuscitation was attempted unsuccessfully.The patient expired post-procedure on (b)(6) 2019.
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Search Alerts/Recalls
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