Model Number RIGID SADDLE RING |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pericardial Effusion (3271); Heart Block (4444)
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Event Date 02/08/2023 |
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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Crd_985 - arb pmcf (b)(6).It was reported that on (b)(6) 2023, a 30mm rigid saddle ring was successfully implanted.On (b)(6) 2023, it was reported that the patient had a complete atrioventricular block and a permeant pacemaker was implanted.The patient was reported to be in stable condition.
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Manufacturer Narrative
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An event of atrioventricular (av) block and pericardial effusion was reported.A returned device assessment could not be performed as the device remains implanted and 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.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Arrhythmia is a potential side effect of the procedure per the rigid saddle ring instructions for use.
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Event Description
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Crd_985 - arb pmcf eu2624-285 (b)(4).It was reported that on 01 february 2023, a 30mm rigid saddle ring was successfully implanted.On (b)(6) 2023, it was reported that the patient had a complete atrioventricular block and a permeant pacemaker was implanted.On (b)(6) 2023, the patient had a pericardial effusion during rehabilitation.On (b)(6) 2023, the patient underwent re-operation.
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Search Alerts/Recalls
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