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Catalog Number AB35W05150135 |
Device Problems
Burst Container or Vessel (1074); Difficult to Remove (1528)
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Patient Problems
Occlusion (1984); Patient Problem/Medical Problem (2688)
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Event Date 03/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the physician intended to use an evercross pta balloon to treat a severely calcified, slightly tortuous lesion, with 80% stenosis, in the mid distal left superficial femoral artery(sfa).The artery diameter and lesion length were reported to be 6mm & 130mm, respectively.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped with no issues identified.A 6fr non-medtronic sheath and a 0.035 non-medtronic guidewire were used with no embolic protection.The device was inflated with a non-medtronic inflation device to 8atm.The device did pass through a previously deployed stent and no resistance was encountered nor excessive force used on advancing the device to the target lesion.The evercross balloon ruptured on first inflation.Difficulties were experienced in removing the balloon so the patient was transferred to surgery for a femoral bypass as the vessel was occluded due to the device rupture.
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Manufacturer Narrative
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Additional information: the evercross pta balloon was used for post-dilation following successful implant of an everflex entrust.The evercross balloon was removed from the stent and then reinserted in the deployed stent (deflated) to use for a wire exchange.The balloon became stuck after wire exchange, inflation was attempted resulting in balloon rupture.All fragments of the evercross were removed the patient¿s vessel.Patient is doing well post-surgery.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: the customer provided two photos of the evercross catheter post-procedure.Both photos are of the same device, but at different angles.The first photo provided focused on the balloon segment of the evercross catheter.It appears the balloon is filled with red biologics and is condensed/compressed in a distal direction.The photo of the balloon in its current state is consistent with a radial fracture of the balloon.The photo also shows a fractured everflex entrust stent.The stent struts were closed around the exterior of the evercross balloon.The portions of the stent which stretched out from the balloon showed fractured ends of the stent struts.The second photo, at a different angle, shows the distal and proximal end of the evercross catheter segment.The photo shows a loaded gray guidewire.The entire evercross catheter was not included the photo.The catheter shaft was likely cut or fractured proximal to the balloon segment.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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