Catalog Number 1804250-23 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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Event Description
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It was reported that the procedure was to treat the left anterior descending (lad) coronary artery.Intravascular ultrasound (ivus) was performed and then the 2.5x23 mm xience skypoint stent was deployed without issue.A non-abbott balloon was used for post dilatation.A perforation was noted in the lad and diagonal arteries.Two additional non-abbott stents were placed in the lad and a coil was placed in the diagonal.The patient was transferred to a higher level of care and was then discharged when they recovered.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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a query of the complaint handling system for the reported / original / relabeled lot was not performed as no device issue or patient effect related to the device was reported.The investigation was unable to determine any issue with the device as no patient effects or device malfunction/failure mode were reported.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: health effect - clinical code 2135 removed; 4582 added.Health effect - impact codes 4641, 4607 removed; 2199 added.Medical device problem code 2993 removed; 3189 added.
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Event Description
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It was reported that the procedure was to treat the left anterior descending (lad) coronary artery.Intravascular ultrasound (ivus) was performed and then the 2.5x23 mm xience skypoint stent was deployed without issue.A non-abbott balloon was used for post dilatation.A perforation was noted in the lad and diagonal arteries.Two additional non-abbott stents were placed in the lad and a coil was placed in the diagonal.The patient was transferred to a higher level of care and was then discharged when they recovered.Subsequent to the initially filed report, it was reported that in the physician's opinion, the xience skypoint stent did not cause or contribute to the perforation.Based on the additional information this complaint would not have been reportable; however, since the initial report has already been filed, this complaint must remain reportable.No additional information was provided.
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Search Alerts/Recalls
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