Catalog Number 1070350-28 |
Device Problems
Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)
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Patient Problems
Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that this was a procedure to treat an 85-90% stenosed lesion with no calcification and no tortuosity in the left circumflex (lcx) coronary artery.The 3.5x 28 mm xience xpedition stent delivery system (sds) was not prepped outside the patient anatomy prior to use.The sds was advanced to the lesion with no resistance.The sds was pressurized but the balloon did not completely inflate.The inflation device was exchanged and pressurized to 10 atmospheres (atms), but the balloon inflated with a waist.Pressure was increased to 11 atms and then the stent was deployed.When negative pressure was applied to remove the delivery system, the balloon failed to deflate and the balloon was stuck to the stent post-deployment.The inflation device was replaced and the balloon slightly deflated.A guide wire was used to puncture the balloon and the balloon partially deflated.The delivery system, guide wire and guiding catheter were removed as one unit.The stent implant was confirmed to be apposed to the vessel wall.The difficulties withdrawing the balloon from the patient's anatomy, resulted in artificial vascular embolism which was treated with another stent implant.Outside the patient anatomy, it was noted that the balloon had not completely deflated.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.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 did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.Additionally, a conclusive cause for the reported patient effect, and its relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effect of obstruction/occlusion is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect(s) of coronary stenting procedures.It was reported that the contrast mixture used during the procedure was 1:2 with saline.It should be noted that the xience xpedition instructions for use states: use 60% contrast diluted 1:1 with normal saline.Additionally, it was reported that the device was not prepared (air aspiration) prior to use.It should be noted that the xience xpedition instructions for use states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach it to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.In this case, it is unknown if the ifu deviations contributed to the reported events.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Device code: 2017 - incorrect prep and contrast incorrectd9: device is not available for evaluation.H6, code 4582 removed.
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Manufacturer Narrative
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A visual and functional inspection was performed on the returned device.The reported inflation problem, difficult or delayed activation, and deflation problem could not be tested due to the device condition.The reported difficult to remove could not be tested as it was based on operational context.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 did not indicate a lot specific quality issue.It was reported that the contrast mixture used during the procedure was 1:2 with saline.It should be noted that the xience xpedition instructions for use states: use 60% contrast diluted 1:1 with normal saline.In this case, it is unknown if the ifu deviation contributed to the reported event.It was reported that the device was not prepared (air aspiration) prior to use.It should be noted that the xience xpedition instructions for use states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach it to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.In this case, it is unknown if the ifu deviations contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported difficulties.Additionally, a conclusive cause for the reported patient effect, and its relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.D9: device available for evaluation.H3: device returned to manufacturer, device evaluated by manufacturer.H6: code 4114 removed.
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Search Alerts/Recalls
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