MAUDE Adverse Event Report: W.L.GORE & ASSOCIATES, INC GORE CARDIOFORM SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number GSX0025A

Device Problems Device Slipped (1584); Difficult to Advance (2920); Positioning Problem (3009)

Patient Problems Death (1802); Embolism (1829)

Event Date 07/05/2018

Event Type  Death  

Event Description

Intervention: device closure of secundum atrial septal defect.Cefazolin 510 mg was administered iv.Flow occlusion diameter.An 18 mm amplatzer sizing balloon was prepared in the usual fashion.A 035 super stiff wire was positioned antegrade across the atrial septa! defect into the left upper pulmonary vein using a 7 french wedge catheter.The wedge catheter and 7 french femoral venous sheath were removed and exchanged for a 10 french short sheath.The sizing balloon over the 035 wire through the skin.The prepared balloon was further de-aired in the right atrium.It was then positioned across the atrial septal communication and inflated until flow occlusion was demonstrated by transesophageal echo.A nice central waist was demonstrated and flow occlusion balloon diameter was 11 to 12 mm.The sizing balloon arid super stiff wire were removed without difficulty.Closure of secundum atrial septa! defect.It was elected to use a gore cardioform 25 mm device, sn (b)(4), exp 2/12/2020, based on the septa! size and flow occlusion diameter.The device was inspected and appeared intact.It was flushed with saline and loaded into the delivery system using standard protocol.The loaded device was transferred through the 10 french femoral venous sheath using standard protocol and advanced into the right atrium.The sheath was then advanced into the left atrium using transesophageal echo guidance.The left disc was performed and the whole system brought towards the atrial septum.The left disorientation was perpendicular to the defect.The left disc was then manipulated so that it aligned better along the atrial septum and the right.This was opened on the right atrial side.There was significant tension on the atrial septum but the device position appeared appropriate with no shunting at the margins of the device.It was elected to lock the device to allow it to reorient appropriately.The device was locked without difficulty.There was significant reorientation and better device position and alignment.Transesophageal echo demonstrated that the device was in appropriate position with no shunting at the margins of the device.All the rims appear to be adequately captured.The device was completely released by removing the attaching thread.Once this was performed transesophageal echo demonstrated that the inferior portion of the device has slipped so that both discs appeared to be in the left atrium.The device was still stable.However it was it was continue to observe the device was slipping further into the left atrium.It was therefore elected to attempt retrieval.As we were attempting to capture the device, the device slipped into the left atrium and was across the mitral valve.While we were trying to get appropriate catheter position the device further embolized into the ascending aorta.Cardiothoracic surgery team was called.Using a 7 french wedge catheter and a jr5 catheter a wire was advanced antegrade into the left carotid artery however it was difficult to advance any retrieval device due to the catheter course.A 6 french sheath was placed in the right femoral artery to attempt retrograde retrieval of the device.The cuff blood pressure and the femoral arterial pressures were low.Patient had sinus rhythm but started to develop sinus bradycardia.External compressions were started.Attempts were made to try to retrieve the device retrograde.This included trying to grab the device with a rat tooth forceps through a 6 french guide catheter.However the guide catheter tip was not strong enough to adequately direct the rat tooth.The short 6 french sheath was exchanged for a curved long 6 french sheath.A descending aortogram was performed through the long 6 french sheath.This demonstrated that the device was lodged in the distal portion of the ascending aorta and 1st part of the transverse aorta.The long sheath was positioned in the ascending aorta to at least created pathway for blood to flow across the device.With cardiac compressions and motion it was difficult to visualize the exact orientation of the device.A 12 mm diameter balloon was prepared in the usual fashion and advanced over the 018 wire through the 6 french sheath and into the ascending aorta proximal to the device.The balloon was inflated and the whole system pullback to see whether the device could be further dislodged and migrated into the descending aorta to facilitate removal as well as blood flow to the carotid arteries.Despite significant force the device would not dislodge or move.The balloon was deflated and removed intact.Cardiac compressions were continued.See code sheet.The cardiothoracic surgical team was in position to perform emergency surgery.

Event Description

Intervention: device closure of secundum atrial septal defect.Cefazolin 510 mg was administered iv.Flow occlusion diameter.An 18 mm amplatzer sizing balloon was prepared in the usual fashion.A 035 superstiff wire was positioned antegrade across the atrial septa! defect into the left upper pulmonary vein using a 7 french wedge catheter.The wedge catheter and 7 french femoral venous sheath were removed and exchanged for a 10 french short sheath.The sizing balloon over the 035 wire through the skin.The prepared balloon was further de-aired in the right atrium.It was then positioned across the atrial septal communication and inflated until flow occlusion was demonstrated by transesophageal echo.A nice central waist was demonstrated and flow occlusion balloon diameter was 11 to 12 mm.The sizing balloon arid superstiff wire were removed without difficulty.Closure of secundum atrial septa! defect.It was elected to use a gore cardioform 25 mm device, sn (b)(4), exp 2/12/2020, based on the septa! size and flow occlusion diameter.The device was inspected and appeared intact.It was flushed with saline and loaded into the delivery system using standard protocol.The loaded device was transferred through the 10 french femoral venous sheath using standard protocol and advanced into the right atrium.The sheath was then advanced into the left atrium using transesophageal echo guidance.The left disc was performed and the whole system brought towards the atrial septum.The left disorientation was perpendicular to the defect.The left disc was then manipulated so that it aligned better along the atrial septum and the right this was opened on the right atrial side.There was significant tension on the atrial septum but the device position appeared appropriate with no shunting at the margins of the device.It was elected to lock the device to allow it to reorient appropriately.The device was locked without difficulty.There was significant reorientation and better device position and alignment.Transesophageal echo demonstrated that the device was in appropriate position with no shunting at the margins of the device.All the rims appear to be adequately captured.The device was completely released by removing the attaching thread.Once this was performed transesophageal echo demonstrated that the inferior portion of the device has slipped so that both discs appeared to be in the left atrium.The device was still stable.However it was continue to observe the device was slipping further into the left atrium.It was therefore elected to attempt retrieval.As we were attempting to capture the device.The device slipped into the left atrium and was across the mitral valve.While we were trying to get appropriate catheter position the device further embolized into the ascending aorta.Cardiothoracic surgery team was called.Using a 7 french wedge catheter and a jr5 catheter a wire was advanced antegrade into the left carotid artery however it was difficult to advance any retrieval device due to the catheter course.A 6 french sheath was placed in the right femoral artery to attempt retrograde retrieval of the device.The cuff blood pressure and the femoral arterial pressures were low.Patient had sinus rhythm but started to develop sinus bradycardia.External compressions were started.Attempts were made to try to retrieve the device retrograde.This included trying to grab the device with a rat tooth forceps through a 6 french guide catheter.However the guide catheter tip was not strong enough to adequately direct the rat tooth.The short 6 french sheath was exchanged for a curved long 6 french sheath.A descending aortogram was performed through the long 6 french sheath.This demonstrated that the device was lodged in the distal portion of the ascending aorta and 1st part of the transverse aorta.The long sheath was positioned in the ascending aorta to at least created pathway for blood to low across the device.With cardiac compressions and motion it was difficult to visualize the exact orientation of the device.A 12 mm diameter balloon was prepared in the usual fashion and advanced over the 018 wire through the 6 french sheath and into the ascending aorta proximal to the device.The balloon was inflated and the whole system pullback to see whether the device could be further dislodged and migrated into the descending aorta to facilitate removal as well as blood flow to the carotid arteries.Despite significant force the device would not dislodge or move.The balloon was deflated and removed intact.Cardiac compressions were continued.See code sheet.The cardiothoracic surgical team was in position to perform emergency surgery.

Event Description

Intervention: device closure of secundum atrial septal defect.Cefazolin 510 mg was administered iv.1.Flow occlusion diameter.An 18 mm amplatzer sizing balloon was prepared in the usual fashion.A 035 superstiff wire was positioned antegrade across the atrial septal defect into the left upper pulmonary vein using a 7 french wedge catheter.The wedge catheter and 7 french femoral venous sheath were removed and exchanged for a 10 french short sheath.The sizing balloon over the 035 wire through the skin.The prepared balloon was further de-aired in the right atrium.It was then positioned across the atrial septal communication and inflated until flow occlusion was demonstrated by transesophageal echo.A nice central waist was demonstrated and flow occlusion balloon diameter was 11 to 12 mm.The sizing balloon arid superstiff wire were removed without difficulty.2.Closure of secundum atrial septal defect.It was elected to use a gore cardioform 25 mm device, based on the septal size and flow occlusion diameter.The device was inspected and appeared intact.It was flushed with saline and loaded into the delivery system using standard protocol.The loaded device was transferred through the 10 french femoral venous sheath using standard protocol and advanced into the right atrium.The sheath was then advanced into the left atrium using transesophageal echo guidance.The left disc was performed and the whole system brought towards the atrial septum.The left disorientation was perpendicular to the defect.The left disc was then manipulated so that it aligned better along the atrial septum and the right this was opened on the right atrial side.There was significant tension on the atrial septum but the device position appeared appropriate with no shunting at the margins of the device.It was elected to lock the device to allow it to reorient appropriately.The device was locked without difficulty.There was significant reorientation and better device position and alignment.Transesophageal echo demonstrated that the device was in appropriate position with no shunting at the margins of the device.All the rims appear to be adequately captured.The device was completely released by removing the attaching thread.Once this was performed transesophageal echo demonstrated that the inferior portion of the device has slipped so that both discs appeared to be in the left atrium.The device was still stable.However it was it was continue to observe the device was slipping further into the left atrium.It was therefore elected to attempt retrieval.As we were attempting to capture the device the device slipped into the left atrium and was across the mitral valve.While we were trying to get appropriate catheter position the device further embolized into the ascending aorta.Cardiothoracic surgery team was called.Using a 7 french wedge catheter and a jr5 catheter a wire was advanced antegrade into the left carotid artery however it was difficult to advance any retrieval device due to the catheter course.A 6 french sheath was placed in the right femoral artery to attempt retrograde retrieval of the device.The cuff blood pressure and the femoral arterial pressures were low.Patient had sinus rhythm but started to develop sinus bradycardia.External compressions were started.Attempts were made to try to retrieve the device retrograde.This included trying to grab the device with a rat tooth forceps through a 6 french guide catheter.However the guide catheter tip was not strong enough to adequately direct the rat tooth.The short 6 french sheath was exchanged for a curved long 6 french sheath.A descending aortogram was performed through the long 6 french sheath.This demonstrated that the device was lodged in the distal portion of the ascending aorta and 1st part of the transverse aorta.The long sheath was positioned in the ascending aorta to at least created pathway for blood to low across the device.With cardiac compressions and motion it was difficult to visualize the exact orientation of the device.A 12 mm diameter balloon was prepared in the usual fashion and advanced over the 018 wire through the 6 french sheath and into the ascending aorta proximal to the device.The balloon was inflated and the whole system pullback to see whether the device could be further dislodged and migrated into the descending aorta to facilitate removal as well as blood flow to the carotid arteries.Despite significant force the device would not dislodge or move.The balloon was deflated and removed intact.Cardiac compressions were continued.The cardiothoracic surgical team was in position to perform emergency surgery.

Event Description

Intervention: device closure of secundum atrial septal defect.Cefazolin 510 mg was administered iv.1.Flow occlusion diameter.An 18 mm amplatzer sizing balloon was prepared in the usual fashion.A 035 superstiff wire was positioned antegrade across the atrial septal defect into the left upper pulmonary vein using a 7 french wedge catheter.The wedge catheter and 7 french femoral venous sheath were removed and exchanged for a 10 french short sheath.The sizing balloon over the 035 wire through the skin.The prepared balloon was further de-aired in the right atrium.It was then positioned across the atrial septal communication and inflated until flow occlusion was demonstrated by transesophageal echo.A nice central waist was demonstrated and flow occlusion balloon diameter was 11 to 12 mm.The sizing balloon arid superstiff wire were removed without difficulty.2.Closure of secundum atrial septal defect.It was elected to use a gore cardioform 25 mm device, based on the septal size and flow occlusion diameter.The device was inspected and appeared intact.It was flushed with saline and loaded into the delivery system using standard protocol.The loaded device was transferred through the 10 french femoral venous sheath using standard protocol and advanced into the right atrium.The sheath was then advanced into the left atrium using transesophageal echo guidance.The left disc was performed and the whole system brought towards the atrial septum.The left disorientation was perpendicular to the defect.The left disc was then manipulated so that it aligned better along the atrial septum and the right this was opened on the right atrial side.There was significant tension on the atrial septum but the device position appeared appropriate with no shunting at the margins of the device.It was elected to lock the device to allow it to reorient appropriately.The device was locked without difficulty.There was significant reorientation and better device position and alignment.Transesophageal echo demonstrated that the device was in appropriate position with no shunting at the margins of the device.All the rims appear to be adequately captured.The device was completely released by removing the attaching thread.Once this was performed transesophageal echo demonstrated that the inferior portion of the device has slipped so that both discs appeared to be in the left atrium.The device was still stable.However it was it was continue to observe the device was slipping further into the left atrium.It was therefore elected to attempt retrieval.As we were attempting to capture the device the device slipped into the left atrium and was across the mitral valve.While we were trying to get appropriate catheter position the device further embolized into the ascending aorta.Cardiothoracic surgery team was called.Using a 7 french wedge catheter and a jr5 catheter a wire was advanced antegrade into the left carotid artery however it was difficult to advance any retrieval device due to the catheter course.A 6 french sheath was placed in the right femoral artery to attempt retrograde retrieval of the device.The cuff blood pressure and the femoral arterial pressures were low.Patient had sinus rhythm but started to develop sinus bradycardia.External compressions were started.Attempts were made to try to retrieve the device retrograde.This included trying to grab the device with a rat tooth forceps through a 6 french guide catheter.However the guide catheter tip was not strong enough to adequately direct the rat tooth.The short 6 french sheath was exchanged for a curved long 6 french sheath.A descending aortogram was performed through the long 6 french sheath.This demonstrated that the device was lodged in the distal portion of the ascending aorta and 1st part of the transverse aorta.The long sheath was positioned in the ascending aorta to at least created pathway for blood to low across the device.With cardiac compressions and motion it was difficult to visualize the exact orientation of the device.A 12 mm diameter balloon was prepared in the usual fashion and advanced over the 018 wire through the 6 french sheath and into the ascending aorta proximal to the device.The balloon was inflated and the whole system pullback to see whether the device could be further dislodged and migrated into the descending aorta to facilitate removal as well as blood flow to the carotid arteries.Despite significant force the device would not dislodge or move.The balloon was deflated and removed intact.Cardiac compressions were continued.The cardiothoracic surgical team was in position to perform emergency surgery.

Event Description

Intervention: device closure of secundum atrial septal defect.Cefazolin 510 mg was administered iv.1.Flow occlusion diameter.An 18 mm amplatzer sizing balloon was prepared in the usual fashion.A 035 superstiff wire was positioned antegrade across the atrial septal defect into the left upper pulmonary vein using a 7 french wedge catheter.The wedge catheter and 7 french femoral venous sheath were removed and exchanged for a 10 french short sheath.The sizing balloon over the 035 wire through the skin.The prepared balloon was further de-aired in the right atrium.It was then positioned across the atrial septal communication and inflated until flow occlusion was demonstrated by transesophageal echo.A nice central waist was demonstrated and flow occlusion balloon diameter was 11 to 12 mm.The sizing balloon arid superstiff wire were removed without difficulty.2.Closure of secundum atrial septal defect.It was elected to use a gore cardioform 25 mm device, based on the septal size and flow occlusion diameter.The device was inspected and appeared intact.It was flushed with saline and loaded into the delivery system using standard protocol.The loaded device was transferred through the 10 french femoral venous sheath using standard protocol and advanced into the right atrium.The sheath was then advanced into the left atrium using transesophageal echo guidance.The left disc was performed and the whole system brought towards the atrial septum.The left disorientation was perpendicular to the defect.The left disc was then manipulated so that it aligned better along the atrial septum and the right this was opened on the right atrial side.There was significant tension on the atrial septum but the device position appeared appropriate with no shunting at the margins of the device.It was elected to lock the device to allow it to reorient appropriately.The device was locked without difficulty.There was significant reorientation and better device position and alignment.Transesophageal echo demonstrated that the device was in appropriate position with no shunting at the margins of the device.All the rims appear to be adequately captured.The device was completely released by removing the attaching thread.Once this was performed transesophageal echo demonstrated that the inferior portion of the device has slipped so that both discs appeared to be in the left atrium.The device was still stable.However it was it was continue to observe the device was slipping further into the left atrium.It was therefore elected to attempt retrieval.As we were attempting to capture the device the device slipped into the left atrium and was across the mitral valve.While we were trying to get appropriate catheter position the device further embolized into the ascending aorta.Cardiothoracic surgery team was called.Using a 7 french wedge catheter and a jr5 catheter a wire was advanced antegrade into the left carotid artery however it was difficult to advance any retrieval device due to the catheter course.A 6 french sheath was placed in the right femoral artery to attempt retrograde retrieval of the device.The cuff blood pressure and the femoral arterial pressures were low.Patient had sinus rhythm but started to develop sinus bradycardia.External compressions were started.Attempts were made to try to retrieve the device retrograde.This included trying to grab the device with a rat tooth forceps through a 6 french guide catheter.However the guide catheter tip was not strong enough to adequately direct the rat tooth.The short 6 french sheath was exchanged for a curved long 6 french sheath.A descending aortogram was performed through the long 6 french sheath.This demonstrated that the device was lodged in the distal portion of the ascending aorta and 1st part of the transverse aorta.The long sheath was positioned in the ascending aorta to at least created pathway for blood to low across the device.With cardiac compressions and motion it was difficult to visualize the exact orientation of the device.A 12 mm diameter balloon was prepared in the usual fashion and advanced over the 018 wire through the 6 french sheath and into the ascending aorta proximal to the device.The balloon was inflated and the whole system pullback to see whether the device could be further dislodged and migrated into the descending aorta to facilitate removal as well as blood flow to the carotid arteries.Despite significant force the device would not dislodge or move.The balloon was deflated and removed intact.Cardiac compressions were continued.The cardiothoracic surgical team was in position to perform emergency surgery.

Event Description

Intervention: device closure of secundum atrial septal defect.Cefazolin 510 mg was administered iv.1.Flow occlusion diameter.An 18 mm amplatzer sizing balloon was prepared in the usual fashion.A 035 superstiff wire was positioned antegrade across the atrial septal defect into the left upper pulmonary vein using a 7 french wedge catheter.The wedge catheter and 7 french femoral venous sheath were removed and exchanged for a 10 french short sheath.The sizing balloon over the 035 wire through the skin.The prepared balloon was further de-aired in the right atrium.It was then positioned across the atrial septal communication and inflated until flow occlusion was demonstrated by transesophageal echo.A nice central waist was demonstrated and flow occlusion balloon diameter was 11 to 12 mm.The sizing balloon arid superstiff wire were removed without difficulty.2.Closure of secundum atrial septal defect.It was elected to use a gore cardioform 25 mm device, based on the septal size and flow occlusion diameter.The device was inspected and appeared intact.It was flushed with saline and loaded into the delivery system using standard protocol.The loaded device was transferred through the 10 french femoral venous sheath using standard protocol and advanced into the right atrium.The sheath was then advanced into the left atrium using transesophageal echo guidance.The left disc was performed and the whole system brought towards the atrial septum.The left disorientation was perpendicular to the defect.The left disc was then manipulated so that it aligned better along the atrial septum and the right this was opened on the right atrial side.There was significant tension on the atrial septum but the device position appeared appropriate with no shunting at the margins of the device.It was elected to lock the device to allow it to reorient appropriately.The device was locked without difficulty.There was significant reorientation and better device position and alignment.Transesophageal echo demonstrated that the device was in appropriate position with no shunting at the margins of the device.All the rims appear to be adequately captured.The device was completely released by removing the attaching thread.Once this was performed transesophageal echo demonstrated that the inferior portion of the device has slipped so that both discs appeared to be in the left atrium.The device was still stable.However it was it was continue to observe the device was slipping further into the left atrium.It was therefore elected to attempt retrieval.As we were attempting to capture the device the device slipped into the left atrium and was across the mitral valve.While we were trying to get appropriate catheter position the device further embolized into the ascending aorta.Cardiothoracic surgery team was called.Using a 7 french wedge catheter and a jr5 catheter a wire was advanced antegrade into the left carotid artery however it was difficult to advance any retrieval device due to the catheter course.A 6 french sheath was placed in the right femoral artery to attempt retrograde retrieval of the device.The cuff blood pressure and the femoral arterial pressures were low.Patient had sinus rhythm but started to develop sinus bradycardia.External compressions were started.Attempts were made to try to retrieve the device retrograde.This included trying to grab the device with a rat tooth forceps through a 6 french guide catheter.However the guide catheter tip was not strong enough to adequately direct the rat tooth.The short 6 french sheath was exchanged for a curved long 6 french sheath.A descending aortogram was performed through the long 6 french sheath.This demonstrated that the device was lodged in the distal portion of the ascending aorta and 1st part of the transverse aorta.The long sheath was positioned in the ascending aorta to at least created pathway for blood to low across the device.With cardiac compressions and motion it was difficult to visualize the exact orientation of the device.A 12 mm diameter balloon was prepared in the usual fashion and advanced over the 018 wire through the 6 french sheath and into the ascending aorta proximal to the device.The balloon was inflated and the whole system pullback to see whether the device could be further dislodged and migrated into the descending aorta to facilitate removal as well as blood flow to the carotid arteries.Despite significant force the device would not dislodge or move.The balloon was deflated and removed intact.Cardiac compressions were continued.The cardiothoracic surgical team was in position to perform emergency surgery.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W.L.GORE & ASSOCIATES, INC; 1505 north fourth st.; p.o. box 2400; flagstaff AZ 86004 2400
• MDR Report Key: 7854618
• MDR Text Key: 119491402
• Report Number: 7854618
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GSX0025A
• Device Catalogue Number: GSX0025A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 1825 DA
• Patient Weight: 17