Model Number AVSM09060 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Stenosis (2263)
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Event Date 10/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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Review of manufacturing records was not performed, as no additional complaint has been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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Event Description
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It was reported through the results of a clinical trial approximately 4-months post index procedure, target lesion stenosis was identified.Standard pta was performed with successful result.It was further reported approximately 9-months post index procedure, target lesion stenosis, access thrombosis, and decreased access blood flow were identified.Standard pta, thrombectomy, and stent graft were used with successful result.Approximately 9-month 24-day post index procedure, target lesion stenosis was identified.Standard pta was used to treat the lesion with successful result.It was further reported approximately 10-month post index procedure, target lesion stenosis, diminished and abnormal thrill and access thrombosis were identified.Standard pta and thrombectomy were used to treat the lesion with successful result.Approximately 10-month 21-day post index procedure, target lesion stenosis, diminished and abnormal thrill and access thrombosis were identified.Standard pta, stent graft and thrombectomy were used to treat the lesion with successful result.It was further reported that approximately 11-month post index procedure, patient experienced 60% target lesion stenosis, numbness and hand pain were identified.Standard pta were used to treat the lesion with successful result.It was further reported approximately 1-year post index procedure, target lesion stenosis was identified.Standard pta was used to treat the lesion with successful result.It was further reported approximately 1-year 1-month post index procedure,70% target lesion stenosis was identified.Standard pta was used to treat the lesion with 0% stenosis.Approximately 1-year 2-month post index procedure, 70% target lesion stenosis and difficulty extracting needles identified.Standard pta was used to treat the lesion with successful result.Approximately 1-year 3-month post index procedure, 50% target lesion stenosis along with prolonged bleeding and pain were experienced.Standard pta was used to treat the lesion with successful result.Approximately 1-year 5-month post index procedure, 70% target lesion stenosis and prolonged bleeding were identified.Standard pta and bare metal stent were used to treat the lesion with successful result.Reportedly, approximately 2-year 21-day post index procedure, 80% target lesion stenosis identified.Standard pta was used to treat the lesion with successful result.The study was completed on (b)(6) 2018.
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Event Description
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It was reported through the results of a clinical trial approximately 4-months post index procedure, target lesion stenosis was identified.Standard pta was performed with successful result.It was further reported approximately 9-months post index procedure, target lesion stenosis, access thrombosis, and decreased access blood flow were identified.Standard pta, thrombectomy, and stent graft were used with successful result.Approximately 9-month 24-day post index procedure, target lesion stenosis was identified.Standard pta was used to treat the lesion with successful result.It was further reported approximately 10-month post index procedure, target lesion stenosis, diminished and abnormal thrill and access thrombosis were identified.Standard pta and thrombectomy were used to treat the lesion with successful result.Approximately 10-month 21-day post index procedure, target lesion stenosis, diminished and abnormal thrill and access thrombosis were identified.Standard pta, stent graft and thrombectomy were used to treat the lesion with successful result.It was further reported that approximately 11-month post index procedure, patient experienced 60% target lesion stenosis, numbness and hand pain were identified.Standard pta were used to treat the lesion with successful result.It was further reported approximately 1-year post index procedure, target lesion stenosis was identified.Standard pta was used to treat the lesion with successful result.It was further reported approximately 1-year 1-month post index procedure,70% target lesion stenosis was identified.Standard pta was used to treat the lesion with 0% stenosis.Approximately 1-year 2-month post index procedure, 70% target lesion stenosis and difficulty extracting needles identified.Standard pta was used to treat the lesion with successful result.Approximately 1-year 3-month post index procedure, 50% target lesion stenosis along with prolonged bleeding and pain were experienced.Standard pta was used to treat the lesion with successful result.Approximately 1-year 5-month post index procedure, 70% target lesion stenosis and prolonged bleeding were identified.Standard pta and bare metal stent were used to treat the lesion with successful result.Reportedly, approximately 2-year 21-day post index procedure, 80% target lesion stenosis identified.Standard pta was used to treat the lesion with successful result.The study was completed on (b)(6)2018.
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Manufacturer Narrative
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After further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is 9681442.This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.Review of manufacturing records was not performed, as no additional complaint has been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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Search Alerts/Recalls
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