Model Number H7493941828300 |
Device Problems
Break (1069); Difficult to Remove (1528); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 10/29/2021 |
Event Type
Death
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Event Description
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It was reported that a balloon rupture and removal difficulties occurred resulting in the detached balloon becoming detached inside the patient.A stenosed target lesion was located in a very mildly tortuous proximal left anterior descending artery.A 3.00 x 28mm synergy xd coronary drug-eluting stent was advanced for treatment.Physician was under the impression that the stent balloon has ruptured, so, he attempted to remove the stent delivery system.However, resistance occurred until the stent delivery system broke off while still inside the deployed stent.The physician was unable to snare the stent balloon.A second stent was deployed inside the original stent to complete the procedure.No patient complications were reported.
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Event Description
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It was reported that a balloon rupture and removal difficulties occurred resulting in the detached balloon becoming detached inside the patient.A stenosed target lesion was located in a very mildly tortuous proximal left anterior descending artery.A 3.00 x 28mm synergy xd coronary drug-eluting stent was advanced for treatment.Physician was under the impression that the stent balloon has ruptured, so, he attempted to remove the stent delivery system.However, resistance occurred until the stent delivery system broke off while still inside the deployed stent.The physician was unable to snare the stent balloon.A second stent was deployed inside the original stent to complete the procedure.No patient complications were reported.It was further reported that the patient passed away.
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Event Description
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It was reported that a balloon rupture and removal difficulties occurred resulting in the detached balloon becoming detached inside the patient.A stenosed target lesion was located in a very mildly tortuous proximal left anterior descending artery (lad).A 3.00 x 28mm synergy xd coronary drug-eluting stent was advanced for treatment.Physician was under the impression that the stent balloon has ruptured, so, he attempted to remove the stent delivery system (sds).However, resistance occurred until the stent delivery system broke off while still inside the deployed stent.The physician was unable to snare the stent balloon.A second stent was deployed inside the original stent to complete the procedure.No patient complications were reported.It was further reported that the patient passed away.It was further reported via medwatch/maude report (b)(4) that when the sds was being withdrawn the shaft of the delivery balloon broke off while inside the coronary artery.Flow was restricted and required emergent intervention.The patient passed away as a result of massive bleeding hours after the vessel was re-perfused.It was further reported via additional information that the lesion in the lad was 90% stenosed.During the deployment of the 3.00 x 28mm synergy xd coronary drug-eluting stent the stent did not fully expand resulting in post dilation was needed with the stent delivery balloon.Poor expansion was still observed.The stent was re-inflated a second time with the negative pressure was applied multiple times however the stent balloon remained inflated.While attempting to remove the stent balloon the shaft detached and was withdrawn from out of the sheath with the balloon remaining in the lad.During removal of the sds the shaft detached.A snare was unsuccessful to retrieve the detached shaft.A non-bsc guidewire crossed the distal to the balloon with attempts to obtain rail with a 2.5x12mm and 2.0x12mm balloon.A guide catheter was utilized to cover the undeflated balloon in an attempt to salvage.With the attempts, timi iii flow was established in the lad with a proximal dissection.Patient was on impella support and medication was administered.
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Manufacturer Narrative
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B2: date of death = (b)(6) 2021.Device evaluated by manufacturer: synergy xd mr us 3.00 x 28mmstent delivery system (sds) was returned for analysis.Device analysis confirmed that a break was located in the distal extrusion.The break was located at 126 cm distal to the distal end of the strain relief.The distal section of the break, including the balloon and tip section of the device was not returned with the device for analysis.An examination of the returned section of extrusion identified multiple kinks.A visual and tactile examination of the hypotube found multiple kinks.No other issues were identified during the product analysis.
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Manufacturer Narrative
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B2: date of death (b)(6) 2021.
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Event Description
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It was reported that a balloon rupture and removal difficulties occurred resulting in the detached balloon becoming detached inside the patient.A stenosed target lesion was located in a very mildly tortuous proximal left anterior descending artery (lad).A 3.00 x 28mm synergy xd coronary drug-eluting stent was advanced for treatment.Physician was under the impression that the stent balloon has ruptured, so, he attempted to remove the stent delivery system (sds).However, resistance occurred until the stent delivery system broke off while still inside the deployed stent.The physician was unable to snare the stent balloon.A second stent was deployed inside the original stent to complete the procedure.No patient complications were reported.It was further reported that the patient passed away.It was further reported via medwatch/maude report (b)(4) that when the sds was being withdrawn the shaft of the delivery balloon broke off while inside the coronary artery.Flow was restricted and required emergent intervention.The patient passed away as a result of massive bleeding hours after the vessel was re-perfused.It was further reported via additional information that the lesion in the lad was 90% stenosed.During the deployment of the 3.00 x 28mm synergy xd coronary drug-eluting stent the stent did not fully expand resulting in post dilation was needed with the stent delivery balloon.Poor expansion was still observed.The stent was re-inflated a second time with the negative pressure was applied multiple times however the stent balloon remained inflated.While attempting to remove the stent balloon the shaft detached and was withdrawn from out of the sheath with the balloon remaining in the lad.During removal of the sds the shaft detached.A snare was unsuccessful to retrieve the detached shaft.A non-bsc guidewire crossed the distal to the balloon with attempts to obtain rail with a 2.5x12mm and 2.0x12mm balloon.A guide catheter was utilized to cover the undeflated balloon in an attempt to salvage.With the attempts, timi iii flow was established in the lad with a proximal dissection.Patient was on impella support and medication was administered.
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Manufacturer Narrative
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B2: date of death = (b)(6) 2021.Device evaluated by manufacturer: synergy xd mr us 3.00 x 28mmstent delivery system (sds) was returned for analysis.Device analysis confirmed that a break was located in the distal extrusion.The break was located at 126 cm distal to the distal end of the strain relief.The distal section of the break, including the balloon and tip section of the device was not returned with the device for analysis.An examination of the returned section of extrusion identified multiple kinks.A visual and tactile examination of the hypotube found multiple kinks.No other issues were identified during the product analysis.
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Event Description
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It was reported that a balloon rupture and removal difficulties occurred resulting in the detached balloon becoming detached inside the patient.A stenosed target lesion was located in a very mildly tortuous proximal left anterior descending artery (lad).A 3.00 x 28mm synergy xd coronary drug-eluting stent was advanced for treatment.Physician was under the impression that the stent balloon has ruptured, so, he attempted to remove the stent delivery system (sds).However, resistance occurred until the stent delivery system broke off while still inside the deployed stent.The physician was unable to snare the stent balloon.A second stent was deployed inside the original stent to complete the procedure.No patient complications were reported.It was further reported that the patient passed away.It was further reported via medwatch/maude report (b)(4) that when the sds was being withdrawn the shaft of the delivery balloon broke off while inside the coronary artery.Flow was restricted and required emergent intervention.The patient passed away as a result of massive bleeding hours after the vessel was re-perfused.It was further reported via additional information that the lesion in the lad was 90% stenosed.During the deployment of the 3.00 x 28mm synergy xd coronary drug-eluting stent the stent did not fully expand resulting in post dilation was needed with the stent delivery balloon.Poor expansion was still observed.The stent was re-inflated a second time with the negative pressure was applied multiple times however the stent balloon remained inflated.While attempting to remove the stent balloon the shaft detached and was withdrawn from out of the sheath with the balloon remaining in the lad.During removal of the sds the shaft detached.A snare was unsuccessful to retrieve the detached shaft.A non-bsc guidewire crossed the distal to the balloon with attempts to obtain rail with a 2.5x12mm and 2.0x12mm balloon.A guide catheter was utilized to cover the undeflated balloon in an attempt to salvage.With the attempts, timi iii flow was established in the lad with a proximal dissection.Patient was on impella support and medication was administered.It was further reported that the patient expired a few hours post procedure.The medical examiner chose not to conduct an autopsy so the cause of the bleeding and cause of death is unknown.
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Search Alerts/Recalls
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