| Model Number 10607 |
| Device Problems
Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Material Deformation (2976)
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| Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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| Event Date 11/11/2019 |
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Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that stent damage occurred.The 70-90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal to mid left anterior descending artery (lad).After prepping the lesion with rotapro atherectomy and with intravascular ultrasound, dilatation was performed with 3.0x15 nc emerge balloon catheters.A 3.00 x 38 synergy drug-eluting stent (des) was advanced to treat the mid lad.However, during deployment, the proximal 10mm of the stent did not expand.Multiple dilatations at 22 atmospheres were done but the issue was not resolved.The device was then forced to be retracted resulting in a severe deformation of the stent.Another 3.00 x 38 synergy des was advanced to treat the proximal lad but the proximal 10mm of the stent did not expand as well.After multiple long duration of inflations at 22 atmospheres, the stent was able to be fully expanded with good result.A 3.50 x 38mm synergy des was also advanced to treat the proximal lad.However, the proximal 10mm of the stent did not expand despite multiple inflations at 22 atmospheres.The device was forcefully retracted into the guide catheter but could not be retracted due to the deformity of the stent strut.Ultimately, the entire system had to be removed and in doing so, the deformed stent became dislodged in the patient's radial artery.The patient was scheduled for a vascular surgery to remove the detached stent from the patient's body.The patient remained hemodynamically stable with minimal pain.No further patient complications were reported.
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that stent damage occurred.The 70-90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal to mid left anterior descending artery (lad).After prepping the lesion with rotapro atherectomy and with intravascular ultrasound, dilatation was performed with 3.0x15 nc emerge balloon catheters.A 3.00 x 38 synergy drug-eluting stent (des) was advanced to treat the mid lad.However, during deployment, the proximal 10mm of the stent did not expand.Multiple dilatations at 22 atmospheres were done but the issue was not resolved.The device was then forced to be retracted resulting in a severe deformation of the stent.Another 3.00 x 38 synergy des was advanced to treat the proximal lad but the proximal 10mm of the stent did not expand as well.After multiple long duration of inflations at 22 atmospheres, the stent was able to be fully expanded with good result.A 3.50 x 38mm synergy des was also advanced to treat the proximal lad.However, the proximal 10mm of the stent did not expand despite multiple inflations at 22 atmospheres.The device was forcefully retracted into the guide cather but could not be retracted due to the deformity of the stent strut.Ultimately, the entire system had to be removed and in doing so, the deformed stent became dislodged in the patient's radial artery.The patient was scheduled for a vascular surgery to remove the detached stent from the patient's body.The patient remained hemodynamically stable with minimal pain.No further patient complications were reported.It was further reported that the patient presented with heart failure and reduced ejection fraction for a staged percutaneous coronary intervention (pci).The target lesion was 100mm in length.The lesion was also prepared using with multiple emerge balloons.A 2.5mm non-bsc balloon was unable to pass so a new 3.0x12mm nc emerge balloon was used.Previously it was reported that the first 3.00x38 synergy stent was forced to be retracted.Now it is reported that it was the stent balloon which was eventually removed causing destruction of the proximal stent architecture.An unsuccessful attempt was made to expand the proximal stent struts using multiple emerge balloons.Rotational atherectomy with a 1.5mm burr was used to disrupt the stent structure followed by serial balloon inflations.A 2.0x12mm emerge balloon was inflated for 20 seconds at 24 atmospheres but on the second inflation at 24 atmospheres for 6 seconds, the balloon ruptured.Another 2.0x15mm emerge balloon was then used followed by 2.5mm, 3.0mm and 3.5mm non compliant balloons with complete expansion.The second 3.00x38mm synergy stent was deployed overlapping the first and had the same malformation.After the third 3.50x38mm synergy stent failed deployment and dislodged, the proximal-mid lad was stented proximally using a 3.5x38mm non-bsc stent and the distal lm into the proximal lad with a 4.5x30mm non-bsc des.There were excellent final angiographic results and intravascular ultrasound confirmed good expansion, apposition and no evidence of edge dissection.
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Manufacturer Narrative
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Device is a combination product.Device evaluated by mfr.: synergy ii us mr 3.00 x 38mm stent delivery system was returned for analysis without a stent.A visual examination of the tip identified tip damage.No stent returned.The balloon was reviewed, and no visible issues were noted.The balloon appeared to have been inflated and deflated.No visible issues were noted with the proximal balloon bond.A hardened/crystalized media was evident in the balloon.A visual and tactile examination of the shaft polymer extrusion identified that the inner lumen within the balloon was off centre and c-shaped.A hardened/crystalized media was evident in the inflation lumen within the mid-shaft and distal shaft.A visual examination of the laser-cut section did not identify any issues.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube.A visual examination of the hub did not identify any issues with the hub including the threads within.No issue noted with hypotube alignment as proximal hypotube positioned correctly.No visible blockages in proximal end of the hypotube.The device was successfully loaded onto and tracked over a 0.014 inch guidewire.An attempt was made to inflate the device using encore inflation device and glycerol water solution, 16atm of pressure applied and the balloon did not inflate.No liquid was seen entering the inflation lumen, no leaks were noted, and pressure held.In an attempt to soften/dissolve the hardened media in the inflation lumen and balloon an encore device filled with water and was left attached to the device with 11atm of pressure applied (balloon did not inflate, and no leaks noted) and the device was placed in a water bath at 37 degrees.After soaking overnight, the device was removed from water bath, the balloon had inflated and the hardened media had softened/dissolved and was no longer visible.A vacuum was pulled to remove this water.A second attempt was then made to inflate the device using encore inflation device and glycerol water solution.16atm of pressure was applied and the balloon inflated without issue.A vacuum was pulled, and the balloon deflated fully without issue in 10 seconds.The water removed from the device inflation lumen after soaking was filtered by slowly pipetting the water into filter paper in a funnel.The glycerol and water solution removed from the device inflation lumen after inflation/deflation test was also filtered by slowly pipetting the water into another filter paper in a funnel.Once all liquid had passed through the filter papers were examined under scope at 10x magnification for any foreign material that may have been inside the inflation lumen.No particles were noted on the filter paper.No other issues were identified during the device analysis.Device evaluated by mfr.: angiographic media was provided.The media review is consistent with the reported event.The three synergy stents used in this case presented difficulties during deployment.The angiographic images recorded the treatment of a high complex and diffuse lesion (distal, middle and proximal) distributed in a tortuous lad with a segment in the lm.The vessel preparation included an atherectomy device.Ivus was also used in this procedure, but images were not provided.Perfusion is observed in the vessel throughout the procedure.Multiple pre-dilatations were conducted prior positioning the first stent at the distal segment of the lad.An extension guide-catheter is also used throughout the procedure and is initially deep seated close to the first stent to provide additional support after unsuccessful expansion of the stent proximal section.The three synergy stents (38 mm length) used in this procedure, targeting the lesions in the lad, recorded similar failure pattern showing unexpansion at the proximal section.During the removal of the delivery system from the first stent, where it was still present the unexpanded section, the stent was stretched maintaining an undeployed proximal section.This section was treated with post dilatations.A 2nd synergy stent was overlapped to cover the first stent and was successful deployed after an initial constrain to the expansion in the proximal section.A nc balloon is also seen constrained during and attempt of pre-dilatation.After treating the area with atherectomy (rota) and various pre-dilatations, a 3rd synergy stent was delivered to treat the proximal lesion.Images of the 3rd synergy stent recording deployments attempts show a constrained proximal section during inflation.This stent failed to expand at the proximal section and was withdrawn.There are 2 series showing the stent at the radial location.Per available images there weren't issues observed when shorted balloons were used for pre or post dilatation, achieving a full expansion at those locations where the constrain is observed in the long stents.This observation includes the location where the nc balloon (30mm length) was constrained.
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Event Description
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It was reported that stent damage occurred.The 70-90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal to mid left anterior descending artery (lad).After prepping the lesion with rotapro atherectomy and with intravascular ultrasound, dilatation was performed with 3.0x15 nc emerge balloon catheters.A 3.00 x 38 synergy drug-eluting stent (des) was advanced to treat the mid lad.However, during deployment, the proximal 10mm of the stent did not expand.Multiple dilatations at 22 atmospheres were done but the issue was not resolved.The device was then forced to be retracted resulting in a severe deformation of the stent.Another 3.00 x 38 synergy des was advanced to treat the proximal lad but the proximal 10mm of the stent did not expand as well.After multiple long duration of inflations at 22 atmospheres, the stent was able to be fully expanded with good result.A 3.50 x 38mm synergy des was also advanced to treat the proximal lad.However, the proximal 10mm of the stent did not expand despite multiple inflations at 22 atmospheres.The device was forcefully retracted into the guide cather but could not be retracted due to the deformity of the stent strut.Ultimately, the entire system had to be removed and in doing so, the deformed stent became dislodged in the patient's radial artery.The patient was scheduled for a vascular surgery to remove the detached stent from the patient's body.The patient remained hemodynamically stable with minimal pain.No further patient complications were reported.It was further reported that the patient presented with heart failure and reduced ejection fraction for a staged percutaneous coronary intervention (pci).The target lesion was 100mm in length.The lesion was also prepared using with multiple emerge balloons.A 2.5mm non-bsc balloon was unable to pass so a new 3.0x12mm nc emerge balloon was used.Previously it was reported that the first 3.00x38 synergy stent was forced to be retracted.Now it is reported that it was the stent balloon which was eventually removed causing destruction of the proximal stent architecture.An unsuccessful attempt was made to expand the proximal stent struts using multiple emerge balloons.Rotational atherectomy with a 1.5mm burr was used to disrupt the stent structure followed by serial balloon inflations.A 2.0x12mm emerge balloon was inflated for 20 seconds at 24 atmospheres but on the second inflation at 24 atmospheres for 6 seconds, the balloon ruptured.Another 2.0x15mm emerge balloon was then used followed by 2.5mm, 3.0mm and 3.5mm non compliant balloons with complete expansion.The second 3.00x38mm synergy stent was deployed overlapping the first and had the same malformation.After the third 3.50x38mm synergy stent failed deployment and dislodged, the proximal-mid lad was stented proximally using a 3.5x38mm non-bsc stent and the distal lm into the proximal lad with a 4.5x30mm non-bsc des.There were excellent final angiographic results and intravascular ultrasound confirmed good expansion, apposition and no evidence of edge dissection.
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Event Description
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It was reported that stent damage occurred.The 70-90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal to mid left anterior descending artery (lad).After prepping the lesion with rotapro atherectomy and with intravascular ultrasound, dilatation was performed with 3.0x15 nc emerge balloon catheters.A 3.00 x 38 synergy drug-eluting stent (des) was advanced to treat the mid lad.However, during deployment, the proximal 10mm of the stent did not expand.Multiple dilatations at 22 atmospheres were done but the issue was not resolved.The device was then forced to be retracted resulting in a severe deformation of the stent.Another 3.00 x 38 synergy des was advanced to treat the proximal lad but the proximal 10mm of the stent did not expand as well.After multiple long duration of inflations at 22 atmospheres, the stent was able to be fully expanded with good result.A 3.50 x 38mm synergy des was also advanced to treat the proximal lad.However, the proximal 10mm of the stent did not expand despite multiple inflations at 22 atmospheres.The device was forcefully retracted into the guide cather but could not be retracted due to the deformity of the stent strut.Ultimately, the entire system had to be removed and in doing so, the deformed stent became dislodged in the patient's radial artery.The patient was scheduled for a vascular surgery to remove the detached stent from the patient's body.The patient remained hemodynamically stable with minimal pain.No further patient complications were reported.It was further reported that the patient presented with heart failure and reduced ejection fraction for a staged percutaneous coronary intervention (pci).The target lesion was 100mm in length.The lesion was also prepared using with multiple emerge balloons.A 2.5mm non-bsc balloon was unable to pass so a new 3.0x12mm nc emerge balloon was used.Previously it was reported that the first 3.00x38 synergy stent was forced to be retracted.Now it is reported that it was the stent balloon which was eventually removed causing destruction of the proximal stent architecture.An unsuccessful attempt was made to expand the proximal stent struts using multiple emerge balloons.Rotational atherectomy with a 1.5mm burr was used to disrupt the stent structure followed by serial balloon inflations.A 2.0x12mm emerge balloon was inflated for 20 seconds at 24 atmospheres but on the second inflation at 24 atmospheres for 6 seconds, the balloon ruptured.Another 2.0x15mm emerge balloon was then used followed by 2.5mm, 3.0mm and 3.5mm non compliant balloons with complete expansion.The second 3.00x38mm synergy stent was deployed overlapping the first and had the same malformation.After the third 3.50x38mm synergy stent failed deployment and dislodged, the proximal-mid lad was stented proximally using a 3.5x38mm non-bsc stent and the distal lm into the proximal lad with a 4.5x30mm non-bsc des.There were excellent final angiographic results and intravascular ultrasound confirmed good expansion, apposition and no evidence of edge dissection.
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Manufacturer Narrative
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Device is a combination product.Device evaluated by mfr.: synergy ii us mr 3.00 x 38mm stent delivery system was returned for analysis without a stent.A visual examination of the tip identified tip damage.No stent returned.The balloon was reviewed, and no visible issues were noted.The balloon appeared to have been inflated and deflated.No visible issues were noted with the proximal balloon bond.A hardened/crystalized media was evident in the balloon.A visual and tactile examination of the shaft polymer extrusion identified that the inner lumen within the balloon was off centre and c-shaped.A hardened/crystalized media was evident in the inflation lumen within the mid-shaft and distal shaft.A visual examination of the laser-cut section did not identify any issues.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube.A visual examination of the hub did not identify any issues with the hub including the threads within.No issue noted with hypotube alignment as proximal hypotube positioned correctly.No visible blockages in proximal end of the hypotube.The device was successfully loaded onto and tracked over a 0.014 inch guidewire.An attempt was made to inflate the device using encore inflation device and glycerol water solution, 16atm of pressure applied and the balloon did not inflate.No liquid was seen entering the inflation lumen, no leaks were noted, and pressure held.In an attempt to soften/dissolve the hardened media in the inflation lumen and balloon an encore device filled with water and was left attached to the device with 11atm of pressure applied (balloon did not inflate, and no leaks noted) and the device was placed in a water bath at 37 degrees.After soaking overnight, the device was removed from water bath, the balloon had inflated and the hardened media had softened/dissolved and was no longer visible.A vacuum was pulled to remove this water.A second attempt was then made to inflate the device using encore inflation device and glycerol water solution.16atm of pressure was applied and the balloon inflated without issue.A vacuum was pulled, and the balloon deflated fully without issue in 10 seconds.The water removed from the device inflation lumen after soaking was filtered by slowly pipetting the water into filter paper in a funnel.The glycerol and water solution removed from the device inflation lumen after inflation/deflation test was also filtered by slowly pipetting the water into another filter paper in a funnel.Once all liquid had passed through the filter papers were examined under scope at 10x magnification for any foreign material that may have been inside the inflation lumen.No particles were noted on the filter paper.No other issues were identified during the device analysis.Device evaluated by mfr.: angiographic media was provided.The media review is consistent with the reported event.The three synergy stents used in this case presented difficulties during deployment.The angiographic images recorded the treatment of a high complex and diffuse lesion (distal, middle and proximal) distributed in a tortuous lad with a segment in the lm.The vessel preparation included an atherectomy device.Ivus was also used in this procedure, but images were not provided.Perfusion is observed in the vessel throughout the procedure.Multiple pre-dilatations were conducted prior positioning the first stent at the distal segment of the lad.An extension guide-catheter is also used throughout the procedure and is initially deep seated close to the first stent to provide additional support after unsuccessful expansion of the stent proximal section.The three synergy stents (38 mm length) used in this procedure, targeting the lesions in the lad, recorded similar failure pattern showing unexpansion at the proximal section.During the removal of the delivery system from the first stent, where it was still present the unexpanded section, the stent was stretched maintaining an undeployed proximal section.This section was treated with post dilatations.A 2nd synergy stent was overlapped to cover the first stent and was successful deployed after an initial constrain to the expansion in the proximal section.A nc balloon is also seen constrained during and attempt of pre-dilatation.After treating the area with atherectomy (rota) and various pre-dilatations, a 3rd synergy stent was delivered to treat the proximal lesion.Images of the 3rd synergy stent recording deployments attempts show a constrained proximal section during inflation.This stent failed to expand at the proximal section and was withdrawn.There are 2 series showing the stent at the radial location.Per available images there weren't issues observed when shorted balloons were used for pre or post dilatation, achieving a full expansion at those locations where the constrain is observed in the long stents.This observation includes the location where the nc balloon (30mm length) was constrained.Simulation testing was carried out to assess if issues with the inflation device setup/connected devices or the anatomy/lesion characteristics could contribute towards the deployment/inflation issues encountered.An attempt made to inflate 3.5x38mm synergy ii des balloon with very high viscosity (100% glycerol) and the glycerol was too thick to inflate balloon.An attempt made to inflate 3.5x38mm synergy ii des balloon with high viscosity (50% glycerol in water solution) and the balloon inflated and deflated without issue.An attempt made to inflate 3.5x38mm synergy ii des balloon with standard testing viscosity glycerol (glycerol/water solution (23ml/70ml) and the balloon inflated and deflated without issue.An attempt made to inflate 3.5x38mm synergy ii des balloon with only 2ml of glycerol (below the 5ml mark on the encore inflation device) and the balloon inflated and deflated without issue.An attempt made to inflate 3.5x38mm synergy ii des balloon with a stopcock which was partially closed, and the balloon inflated and deflated without issue.An attempt made to inflate 3.5x38mm synergy ii des balloon and deploy the stent within a lesion model.The balloon inflated and stent deployed in the non-constrained areas only, conforming to the shape of the lesion.An attempt made to withdraw (pull pack) the balloon, this caused severe stretching of the stent, the balloon was withdrawn from the stent when force was used.A piece of an elastic material was dropped at the connection in the lumen between the deflator and the stopcock attempting to obstruct (clog) the inflation lumen.An attempt made to inflate 4x38mm synergy ii des balloon with this stopcock attached.The balloon inflated at the distal and proximal ends leaving a mid-section portion of the stent unexpanded.An attempt made to inflate 3.5x16mm promus premier balloon using the same stopcock.This shorter balloon inflated, and stent expanded.
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Search Alerts/Recalls
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