Model Number 10605 |
Device Problem
Break (1069)
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Patient Problem
Embolism (1829)
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Event Date 05/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.Age: (b)(6).
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Event Description
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It was reported that shaft break and embolization occurred.The patient presented with chest pain, rising troponins, and electrocardiogram changes which is consistent with ischemia.The target lesion was located in the left anterior descending artery (lad) and diagonal (diag) branch.Due to disease of the lad and enlargement of the diag branch, double kissing crush technique was performed.After a non-bsc wire was used to cross the lesion, pre-dilatation was performed.A 2.50 x 28 synergy drug-eluting stent (des) was advanced through the diag; however, it had an issue with the guider and could not pass the stent into the lad.The stent was frozen in place and was wrapped around the lad balloon.They had to be deployed the stent in the diag.Upon removal of the delivery system, it was noted that the shaft fractured in the guider and the balloon separated from the catheter.A portion of the detached fragment remained in the guider where it was trapped and removed.The other portion of the balloon embolized to the descending aorta and was successfully removed using a bioptome despite numerous unsuccessful attempts.An 8f sheath was then placed and with guide liner support, a 1.25mm balloon catheter was advanced past the stent portion from the diag into the lad.Progression dilatation was performed with multiple balloon catheters with sizes 1.25, 2.0, 2.5 respectively.The lad was then stented with a 2.75 x 38 syngergy des, followed by a 3.0 x 20 des.The diag was then recrossed and simultaneous kissing balloon techniques were performed and the lad was post-dilated in multiple locations with a 3.25 non-compliant balloon at up to 18 atmospheres.Angiography revealed excellent result throughout the diag and the lad.Femoral angiography showed appropriate catheter placement in the common femoral artery and the procedure was completed after closure of the cath site with an 8f non-bsc device.No further patient complications were reported.
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Event Description
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It was reported that shaft break and embolization occurred.The patient presented with chest pain, rising troponins, and electrocardiogram changes which is consistent with ischemia.The target lesion was located in the left anterior descending artery (lad) and diagonal (diag) branch.Due to disease of the lad and enlargement of the diag branch, double kissing crush technique was performed.After a non-bsc wire was used to cross the lesion, pre-dilatation was performed.A 2.50 x 28 synergy drug-eluting stent (des) was advanced through the diag; however, it had an issue with the guider and could not pass the stent into the lad.The stent was frozen in place and was wrapped around the lad balloon.They had to be deployed the stent in the diag.Upon removal of the delivery system, it was noted that the shaft fractured in the guider and the balloon separated from the catheter.A portion of the detached fragment remained in the guider where it was trapped and removed.The other portion of the balloon embolized to the descending aorta and was successfully removed using a bioptome despite numerous unsuccessful attempts.An 8f sheath was then placed and with guide liner support, a 1.25mm balloon catheter was advanced past the stent portion from the diag into the lad.Progression dilatation was performed with multiple balloon catheters with sizes 1.25, 2.0, 2.5 respectively.The lad was then stented with a 2.75 x 38 syngergy des, followed by a 3.0 x 20 des.The diag was then recrossed and simultaneous kissing balloon techniques were performed and the lad was post-dilated in multiple locations with a 3.25 non-compliant balloon at up to 18 atmospheres.Angiography revealed excellent result throughout the diag and the lad.Femoral angiography showed appropriate catheter placement in the common femoral artery and the procedure was completed after closure of the cath site with an 8f non-bsc device.No further patient complications were reported.
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Manufacturer Narrative
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Device is a combination product.B3 date of event: used the first date of the month of the aware date as no event date was provided.A partial synergy ii us mr 2.50 x 38 mm device from distal tip to polymer extrusion was returned for analysis without the hypotube shaft including the hub/manifold.A visual examination of the stent found the stent was not returned for analysis since it had been deployed in the patient.The balloon body was reviewed; and no issues were noted.Blood like substance in the balloon and inflation lumen of the distal shaft was observed during analysis.There was indication that positive and negative pressure were applied to balloon.A visual and microscopic examination of the tip showed signs of damage on the distal edge of the tip.Tip damage most likely occurred when the tip was pushed against a restriction.The hypotube section of the device was not returned for analysis.A visual and tactile examination of the outer extrusion and mid-shaft section and visual examination of the inner extrusion found a break in the polymer extrusion section at 255 mm proximal to distal tip (the break was in the port bond, within the exchange port).This type of damage most likely occurred due to excessive force that could have been applied to the delivery system during withdrawal attempts.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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