Lot Number 0031225210 |
Device Problems
Break (1069); Inflation Problem (1310)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 01/31/2024 |
Event Type
Injury
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Manufacturer Narrative
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E1: initial reporter address 1: (b)(6).
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Event Description
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It was reported that a shaft break occurred, the device was unretrieved requiring additional surgery.The 70% stenosed target lesion was located in the mildly tortuous and moderately to severely calcified left anterior descending artery (lad).A 2.50 x 48mm synergy xd drug eluting stent was advanced for treatment together with a non-bsc guide catheter.However, upon inserting the second 2.5 x 48mm synergy, the physician was using a non-bsc guide catheter to help advance the stents, it was noted the second stent was not positioned as expected.Upon repositioning, the stent was successfully deployed.However, it was noted the balloon was not inflating.A second indeflator was opened and upon trying to deploy the stent again, it was noted the balloon was not inflating and blood was coming back into the indeflator.Fluoroscopy confirmed the stent was not deployed and the non-bsc guide catheter was advanced over the proximal portion of the stent to retrieve.Upon trying to retrieve the stent, the hypotube and shaft broke leaving the stent deployment system with balloon in the patients lad.It was not attempted to snare the system out, instead it was left in the patient and transferal of the patient emergently to another facility for emergent open heart surgery occurred.
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Event Description
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It was reported that a shaft break occurred, the device was unretrieved requiring additional surgery.The 70% stenosed target lesion was located in the mildly tortuous and moderately to severely calcified left anterior descending artery (lad).A 2.50 x 48mm synergy xd drug eluting stent was advanced for treatment together with a non-bsc guide catheter.However, upon inserting the second 2.5 x 48mm synergy, the physician was using a non-bsc guide catheter to help advance the stents, it was noted the second stent was not positioned as expected.Upon repositioning, the stent was successfully deployed.However, it was noted the balloon was not inflating.A second indeflator was opened and upon trying to deploy the stent again, it was noted the balloon was not inflating and blood was coming back into the indeflator.Fluoroscopy confirmed the stent was not deployed and the non-bsc guide catheter was advanced over the proximal portion of the stent to retrieve.Upon trying to retrieve the stent, the hypotube and shaft broke leaving the stent deployment system with balloon in the patients lad.It was not attempted to snare the system out, instead it was left in the patient and transferal of the patient emergently to another facility for emergent open heart surgery occurred.
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Manufacturer Narrative
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E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: synergy xd mr us 2.50 x 48mm was returned for analysis.A visual and tactile examination identified no kinks along the hypotube.A visual examination of the distal extrusion identified a break in the midshaft extrusion.The break was located at 117.7cm distal to the distal end of the strain relief.The distal section of the break including the distal extrusion, balloon and tip sections of the device was not returned for analysis.A microscopic examination identified a break in the lasercut region.The break was contained in a section of the midshaft extrusion.
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Search Alerts/Recalls
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