Catalog Number 1500350-18 |
Device Problems
Material Separation (1562); Device Damaged by Another Device (2915)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The 3.5x12mm xience sierra device referenced is being filed under a separate medwatch report number.
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Event Description
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It was reported that the procedure was to treat a de novo, 80% stenosed, mildly calcified and mildly tortuous vessel in the left anterior descending (lad) artery.The 2.5x33mm xience sierra stent was deployed in the distal lad and the 3.5x18mm xience sierra was deployed in the proximal lad.A 3.5x12mm xience sierra was implanted in between the first two stents as it was noted there was an uncovered area between the first two stents.A 5.5x8mm non-compliant balloon was used to post dilate as standard practice to optimize the proximal segment and during this post dilatation, it was found that the 3.5x18 mm xience sierra in the proximal lad separated and a part had moved to the aorta under angiography.The separated portion of the stent was deliberately flared as much as possible in the aorta to try and reduce the struts sticking out.There was no reported adverse patient sequela.There was no significant delay in the procedure.
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Event Description
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It was reported that the procedure was to treat a de novo, 80% stenosed, mildly calcified and mildly tortuous vessel in the left anterior descending (lad) artery.The 2.5x33mm xience sierra stent was deployed in the distal lad and the 3.5x18mm xience sierra was deployed in the proximal lad.A 3.5x12mm xience sierra was implanted in between the first two stents as it was noted there was an uncovered area between the first two stents.A 5.5x8mm non-compliant balloon was used to post dilate as standard practice to optimize the proximal segment and during this post dilatation, it was found that the 3.5x18 mm xience sierra in the proximal lad separated and a part had moved to the aorta under angiography.The separated portion of the stent was deliberately flared as much as possible in the aorta to try and reduce the struts sticking out.There was no reported adverse patient sequela.There was no significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: patient was discharged and stable as of discharge day and did not require any additional medical/surgical intervention after the procedure.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 review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the 3.5x12 mm stent interacted with the 3.5x18 mm stent during post dilation causing the reported device damaged by another (implanted stent) and material separation (stent).The migration into the aorta of the damaged stent resulted in unintended stent placement (foreign body in patient) and additional post dilatation was performed (unintended medical intervention).Additionally, it should be noted that an abbott vascular clinical specialist reviewed the cine images confirming the xience sierra des 3.50x18 rx appeared to exhibit a fracture of the link.Based upon the information in the report it cannot be confirmed that the 5.5 mm post-dilatation balloon was inflated beyond 5.5 mm, which is the maximum post-dilatation expansion capability for this 3.5 mm stent diameter, per the product specification.As it appears that the 3.5x 18 mm diameter stent was deployed at the nominal diameter then the likely probable cause for the stent to migrate into the aorta is due to the inflation of the 5.5 mm balloon in a stent that was not initially apposed to the vessel wall, causing the stent to migrate partially into the aorta.A product malfunction could not be confirmed.Based on the reviewed cine image information it is likely over expansion during post dilation of the implanted 3.5x18 mm stent caused the reported device damaged by another and material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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