Model Number 9-ITV06F45/60 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Vascular Dissection (3160)
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Event Date 03/11/2014 |
Event Type
Injury
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Event Description
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During a procedure to implant a 9mm amplatzer septal occluder (aso), the 6f amplatzer torqvue 45 delivery system reportedly dissected the right iliac vein and the aso was determined to be too large.Five stents were used to repair the dissection and a 7mm aso was implanted.
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Manufacturer Narrative
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The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of this investigation are inconclusive because the product was not returned for analysis; however, review of the device history record confirmed the product met manufacturing requirements prior to shipment.The cause of the reported event remains unknown.
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Search Alerts/Recalls
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