Model Number DUCT OCCLUDER |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2022 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2022, a 10-8mm amplatzer duct occluder was successfully implanted in a patient.It was noted during procedure that there was a residual shunt detected via angiography examination after full deployment/implant of the occluder.The residual shunt was not considered the patient was checked again 24 hours after implant and an echocardiogram detected the same residual shunt.There was no intervention performed.The patient was stable and discharged at the time of report and told to call to schedule a follow up appointment a month after the implant procedure.
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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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Manufacturer Narrative
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An event of residual shunt 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 that the product met all specifications.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 regard to manufacture, design, or labeling.H6 health effect - clinical code: code 4580 removed.
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Event Description
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Subsequent to the previously filed report, additional information was received that the 10-8mm amplatzer duct occluder was sized using fluoroscopic examination.There had been no difficulty experienced implanting the occluder into the patient's patent ductus arteriosus.The occluder had been implanted using a 7f amplatzer torqvue delivery system.It presumed that the 10-8mm amplatzer duct occluder was missing it's standard polyester fabric, but still remains implanted.The 10-8mm amplatzer duct occluder was not mishandled or damaged during device preparation.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.There was no intervention required/performed for the residual shunt that persisted, but the patient will be re-evaluated during a 30 day follow up appointment.The patient was discharged at the time of report.
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Search Alerts/Recalls
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