Catalog Number S-50-040-120-P6 |
Device Problems
Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Difficult to Remove (1528)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that the procedure was performed to treat a lesion with heavy calcification in the popliteal artery.The lesion was pre-dilated with 4 mm balloon and dilated to nominal.The supera stent system was advanced to the target lesion.During deployment resistance was felt due to the heavy calcification; therefore, the physician pulled the device back slightly for the stent to release and the stent was deployed successfully at the target lesion.However, during removal resistance was felt and the nosecone/tip had separated inside the middle portion of the stent implant and remained in the patient.Therefore, the procedure was completed by performing femoral popliteal bypass surgery.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Visual inspection was performed on the returned device.The reported deployment issue and difficulty removing was unable to be confirmed as the stent had already been fully deployed.The tip separation was confirmed.It is likely that the stent was partially deployed within the introducer sheath and during withdrawal of the delivery system, the tip detachment occurred as the partially deployed stent was pulled into the reduced clearance of the stent.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined the reported difficulties were likely related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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