Catalog Number 1070300-48 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2021 |
Event Type
malfunction
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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 the procedure was performed to treat a lesion in the mildly calcified, moderately tortuous, 80% stenosed proximal left anterior descending coronary artery.After pre-dilatation with unspecified 1.2x8mm and 2x8mm balloons, a 3x48mm xience xpedition stent delivery system (sds) was advanced.During deployment, it was noted that there was no stent present on the device.Per hospital staff, they did not notice whether the stent was present on the sds prior to advancement in patient anatomy.A same sized xience xpedition stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Event Description
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It was reported that the procedure was performed to treat a lesion in the mildly calcified, moderately tortuous, 80% stenosed proximal left anterior descending coronary artery.After pre-dilatation with unspecified 1.2x8mm and 2x8mm balloons, a 3x48mm xience xpedition stent delivery system (sds) was advanced.During deployment, it was noted that there was no stent present on the device.Per hospital staff, they did not notice whether the stent was present on the sds prior to advancement in patient anatomy.A same sized xience xpedition stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, the account confirmed the xience xpedition was prepped prior to sheath/stylet removal.No additional information was provided.
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Manufacturer Narrative
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Device code 2017 - incorrect prep a visual inspection was performed on the returned device.The reported missing component was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.It was reported that the xience xpedition was prepped prior to sheath/stylet removal.It should be noted that the xience xpedition, everolimus eluting coronary stent system (eecss) instructions for use specifies to remove the product mandrel and protective stent sheath by grasping the catheter just proximal to the stent (at the proximal balloon bond site), and with the other hand, grasp the stent protector and gently remove distally.Ifu states: flush the guide wire lumen with hepns using the flushing tool supplied with the product.In addition, it was reported that the stent implant was not on the balloon after the device had been advanced into the anatomy.It should be noted that the xience xpedition, everolimus eluting coronary stent system (eecss) instructions for use states: prior to using the xience xpedition 48 everolimus eluting coronary stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.The investigation was unable to determine a conclusive cause for the reported missing components.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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Search Alerts/Recalls
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