Model Number RIGID SADDLE RING |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pneumothorax (2012); Pericarditis (4448)
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Event Date 01/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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(b)(4).It was reported that on (b)(6) 2023 a 32mm rigid saddle ring was selected for an implant.During the procedure, the patient had signs of a pericarditis which was treated with adhesiolysis.On (b)(6) 2023 the patient had systemic inflammatory response syndrome post procedure; noradrenalin dose was increased.On (b)(6) 2023, pneumothorax right sided was noted, however no treatment was provided.Patient stable and the device is working as intended.
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Manufacturer Narrative
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An event of systemic inflammatory response syndrome post procedure, right sided pneumothorax and pericarditis were reported.A returned device assessment could not be performed as the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the device was working as intended.There was no allegation of malfunction against the abbott device.Based on the information received, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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Search Alerts/Recalls
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