Model Number PED-325-16 |
Device Problems
Break (1069); Migration or Expulsion of Device (1395)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device remains implant inside the patient.The reported ped pushwire has not been returned for evaluation.Therefore, the cause of this clinical experience cannot be conclusive determined.Should the product be returned for analysis, a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that the pushwire of a pipeline flex embolization device (ped) broke inside the patient during a flow diversion procedure.The device was used to treat a pediatric patient's fusiform aneurysm located at the left internal carotid artery measured 3.6mm in max diameter.The landing zone vessel diameters were 2.7mm distally and 2.84mm proximally.Vessel tortuosity was described as minimal.This patient has history of tuberous sclerosis complex which causes frequent growth of cysts and tumors.The patient needs frequent mri for his lifetime.It was reported the device was prepared following the instruction for use.No friction was encountered when the ped was advanced through the micro catheter.The ped was never resheathed prior to the reported event.During the deployment of the ped in the anterior cerebral artery, the physician attempted to resheath the ped.At this point, the delivery wire broke at the proximal marker, so the ped was deployed.The ped landed on the desired location with adequate wall apposition.Attempt was made to snare the broke wire from the patient.The retrieval effort was unsuccessful.The snare device also moved the deployed.Ped distally.As a result, a second ped was placed for the patient.The fractured delivery wire was left inside the patient.
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient was discharge with instruction of no mri until contacted by the physician.
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Search Alerts/Recalls
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