Model Number LOBO-7 |
Device Problem
Migration (4003)
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Patient Problems
Necrosis (1971); Pain (1994); Pulmonary Edema (2020); Inadequate Pain Relief (2388); Hypervolemia (2664); Device Embedded In Tissue or Plaque (3165)
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Event Date 06/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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The lobo-7 device remains implanted in the patient, remains stable, and is not available for evaluation.The device identifiers were provided and the lot history records were reviewed; there were no deviations or nonconformances relevant to the reportable event.Intraoperative images were sent to the manufacturer for evaluation and the investigation is underway.The findings will be filed in a supplemental report.Implant migration and occlusion of unintended vessel are listed in the device labeling as potential complications / adverse events.Reference #: (b)(4).
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Event Description
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Patient was treated for a splenic artery aneurysm measuring 2.5 - 3 cm.A lobo-7 device was deployed in the splenic artery distal to the aneurysm and migrated into an upper pole branch of the splenic artery.The device could not be retrieved with a snare and the physician elected to leave it in place.The aneurysm was successfully treated with lobo-9 and embolic coils.The spleen was partially infarcted, but no long-term effects to splenic function are anticipated by the physician.Patient was discharged following the procedure with pain medication.The patient returned to the hospital and was admitted for pain management.During hospitalization, the patient was treated for pain and fluid overload (including pulmonary edema), and was subsequently discharged.
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Manufacturer Narrative
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Angiographic images were sent to the manufacturer and evaluated.Based on the image and dimensional analysis, it was determined that the lobo-7 device was placed in a vessel larger than indicated for use.The investigation concluded that the implant migration was attributed to inadvertent use error and there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.Reference #: (b)(4).
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Search Alerts/Recalls
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