Model Number 9-TV45X45-12F-100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pulmonary Embolism (1498)
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Event Date 08/16/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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On (b)(6) 2016, an amplatzer amulet (acp2) was implanted using a 12f amplatzer torqvue 45 x 45 delivery sheath (tv45x45).On (b)(6) 2016, bilateral pulmonary emboli were observed.The patient was hospitalized and treated with heparin which led to thrombocytopenia.Heparin was discontinued and coumadin was started.(clinical study patient id: (b)(6)).
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Search Alerts/Recalls
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