MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE 14F; INTRODUCER, CATHETER

Model Number 10445

Device Problems Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 02/22/2024

Event Type  Death  

Event Description

It was reported that hemorrhage and death occurred.Procedure summary: the native aortic annulus measured 24.2mm in diameter with mild calcification noted.The iliofemoral arteries contained moderate to severe tortuosity, and moderate calcium.Vascular access was attempted via a right transfemoral approach yet was unsuccessful, so the vessel was attempted to be closed.Vascular access was subsequently attempted via a left transfemoral approach despite worse tortuosity.A safari2 guidewire was advanced and positioned without difficulty.Radial access was obtained successfully for fluoroscopy and pigtail catheter use.Pre-close technique was inserted on the left femoral artery with a non-bsc vessel closure device.A 14f isleeve introducer sheath was attempted to be inserted and had trouble advancing.The safari2 was exchanged for a non-bsc guidewire to strengthen the femoral artery.After several attempts, the isleeve introducer sheath was placed within the intended location yet a large bend was noted due to the vessel tortuosity.A size medium acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds).The acurate neo2 tf ds was attempted to be inserted into the isleeve introducer sheath but could not advance fully through the acurate neo2 tf ds due to the severe tortuosity and was stuck at the noted bend in the isleeve introducer sheath.After several attempts to position, the physicians removed the loaded acurate neo2 tf ds and isleeve introducer sheath without any further consequence.The isleeve introducer sheath was inspected and there was no damage or breaks noted.The acurate neo2 tf ds and valve were inspected and despite a bend noted on the system, valve deployment was tested and successful at the table outside of the patient.Vascular access was reattempted via a right femoral approach and was successful.The isleeve introducer sheath was reinserted in the right femoral artery, and a non-bsc aortic valve was prepared and implanted successfully.Both right and left transfemoral vascular access sites were closed with a non-bsc vessel closure device.The patient was stable and fully conscious when the procedure was concluded.In the physician's opinion, the patient's severe vessel tortuosity and large pannus were considerations in the increased difficulty of vascular access.Patient status: two (2) hours post procedure, the patient died due to a bleeding complication.The location of the bleeding (right versus left side) is unknown at this time, but the official cause of death was damage to the femoral artery below the bifurcation to the abdominal artery.

Manufacturer Narrative

Device evaluated by mfr.: the returned isleeve sheath was received for analysis and the reported event of device damage was confirmed as the isleeve sheath had numerous kinks.There was a sheath tear/split at one of the seams from the tip to approx.14.5cm cm from the isleeve sheath tip.The other two seams were expanded, and the tip was not expanded.The expanded seams of the isleeve occurred along the seam line, and is expected use of the device, as the seams are designed to expand with use to allow passage of delivery system and balloon aortic valvuloplasty (bav) during the procedure; therefore, this is not considered damage to the device.The reported difficulties to advance were not able to be confirmed, as the clinical circumstances could not be replicated.However, the confirmed torn/split sheath and kinks were most likely due to the difficulties to advance.Pre-procedural planning computed tomography (ct) media was provided to assist in the investigation and was reviewed by bsc medical safety.The ct starts by showing the native aortic annulus with 24.3mm of perimeter derived diameter.The native aortic annulus was not calcified but leaflets were moderately calcified.The left ventricle outflow tract (lvot) had a perimeter derived diameter of 25.7mm and was not calcified.Peripheral arteries evidenced a right femoral artery that appeared extremely tortuous and calcified, with a ring of calcium just below the bifurcation with a narrowed lumen area.The left femoral artery was extremely tortuous, calcified, but had a lumen compatible with the use of isleeve introducer sheath.Based solely on the images provided, no conclusion can be made as to what potentially led to a perforation in the iliac.It is reasonable to speculate, though, that based on the intense calcification and tortuosity of the access site, coupled with the forces applied to advance the isleeve and acurate neo2 tf ds could have played a role in the outcome of the patient.No procedural media was provided.B5: information added.H6: codes added for product investigation.

Event Description

It was reported that hemorrhage and death occurred.Procedure summary: the native aortic annulus measured 24.2mm in diameter with mild calcification noted.The iliofemoral arteries contained moderate to severe tortuosity, and moderate calcium.Vascular access was attempted via a right transfemoral approach yet was unsuccessful, so the vessel was attempted to be closed.Vascular access was subsequently attempted via a left transfemoral approach despite worse tortuosity.A safari2 guidewire was advanced and positioned without difficulty.Radial access was obtained successfully for fluoroscopy and pigtail catheter use.Pre-close technique was inserted on the left femoral artery with a non-bsc vessel closure device.A 14f isleeve introducer sheath was attempted to be inserted and had trouble advancing.The safari2 was exchanged for a non-bsc guidewire to strengthen the femoral artery.After several attempts, the isleeve introducer sheath was placed within the intended location yet a large bend was noted due to the vessel tortuosity.A size medium acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds).The acurate neo2 tf ds was attempted to be inserted into the isleeve introducer sheath but could not advance fully through the acurate neo2 tf ds due to the severe tortuosity and was stuck at the noted bend in the isleeve introducer sheath.After several attempts to position, the physicians removed the loaded acurate neo2 tf ds and isleeve introducer sheath without any further consequence.The isleeve introducer sheath was inspected and there was no damage or breaks noted.The acurate neo2 tf ds and valve were inspected and despite a bend noted on the system, valve deployment was tested and successful at the table outside of the patient.Vascular access was reattempted via a right femoral approach and was successful.The isleeve introducer sheath was reinserted in the right femoral artery, and a non-bsc aortic valve was prepared and implanted successfully.Both right and left transfemoral vascular access sites were closed with a non-bsc vessel closure device.The patient was stable and fully conscious when the procedure was concluded.In the physician's opinion, the patient's severe vessel tortuosity and large pannus were considerations in the increased difficulty of vascular access.Patient status: two (2) hours post procedure, the patient died due to a bleeding complication.The location of the bleeding (right versus left side) is unknown at this time.The official cause of death was damage to the femoral artery below the bifurcation to the abdominal artery.It was further corrected that vascular access was not reattempted via a right femoral approach, and instead the left femoral access was retained with a non-bsc guidewire and isleeve reinserted and non-bsc aortic valve implanted.

Manufacturer Narrative

Device evaluated by mfr.: the returned isleeve sheath was received for analysis and the reported event of device damage was confirmed as the isleeve sheath had numerous kinks.There was a sheath tear/split at one of the seams from the tip to approx.14.5cm cm from the isleeve sheath tip.The other two seams were expanded, and the tip was not expanded.The expanded seams of the isleeve occurred along the seam line, and is expected use of the device, as the seams are designed to expand with use to allow passage of delivery system and balloon aortic valvuloplasty (bav) during the procedure; therefore, this is not considered damage to the device.The reported difficulties to advance were not able to be confirmed, as the clinical circumstances could not be replicated.However, the confirmed torn/split sheath and kinks were most likely due to the difficulties to advance.Pre-procedural planning computed tomography (ct) media was provided to assist in the investigation and was reviewed by bsc medical safety.The ct starts by showing the native aortic annulus with 24.3mm of perimeter derived diameter.The native aortic annulus was not calcified but leaflets were moderately calcified.The left ventricle outflow tract (lvot) had a perimeter derived diameter of 25.7mm and was not calcified.Peripheral arteries evidenced a right femoral artery that appeared extremely tortuous and calcified, with a ring of calcium just below the bifurcation with a narrowed lumen area.The left femoral artery was extremely tortuous, calcified, but had a lumen compatible with the use of isleeve introducer sheath.Based solely on the images provided, no conclusion can be made as to what potentially led to a perforation in the iliac.It is reasonable to speculate, though, that based on the intense calcification and tortuosity of the access site, coupled with the forces applied to advance the isleeve and acurate neo2 tf ds could have played a role in the outcome of the patient.No procedural media was provided.B5: information added, h6: codes added for product investigation, h6: evaluation conclusion code corrected.

Event Description

It was reported that hemorrhage and death occurred.Procedure summary the native aortic annulus measured 24.2mm in diameter with mild calcification noted.The iliofemoral arteries contained moderate to severe tortuosity, and moderate calcium.Vascular access was attempted via a right transfemoral approach yet was unsuccessful, so the vessel was attempted to be closed.Vascular access was subsequently attempted via a left transfemoral approach despite worse tortuosity.A safari2 guidewire was advanced and positioned without difficulty.Radial access was obtained successfully for fluoroscopy and pigtail catheter use.Pre-close technique was inserted on the left femoral artery with a non-bsc vessel closure device.A 14f isleeve introducer sheath was attempted to be inserted and had trouble advancing.The safari2 was exchanged for a non-bsc guidewire to strengthen the femoral artery.After several attempts, the isleeve introducer sheath was placed within the intended location yet a large bend was noted due to the vessel tortuosity.A size medium acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds).The acurate neo2 tf ds was attempted to be inserted into the isleeve introducer sheath but could not advance fully through the acurate neo2 tf ds due to the severe tortuosity and was stuck at the noted bend in the isleeve introducer sheath.After several attempts to position, the physicians removed the loaded acurate neo2 tf ds and isleeve introducer sheath without any further consequence.The isleeve introducer sheath was inspected and there was no damage or breaks noted.The acurate neo2 tf ds and valve were inspected and despite a bend noted on the system, valve deployment was tested and successful at the table outside of the patient.Vascular access was reattempted via a right femoral approach and was successful.The isleeve introducer sheath was reinserted in the right femoral artery, and a non-bsc aortic valve was prepared and implanted successfully.Both right and left transfemoral vascular access sites were closed with a non-bsc vessel closure device.The patient was stable and fully conscious when the procedure was concluded.In the physician's opinion, the patient's severe vessel tortuosity and large pannus were considerations in the increased difficulty of vascular access.Patient status two (2) hours post procedure, the patient died due to a bleeding complication.The location of the bleeding (right versus left side) is unknown at this time.The official cause of death was damage to the femoral artery below the bifurcation to the abdominal artery.It was further corrected that vascular access was not reattempted via a right femoral approach, and instead the left femoral access was retained with a non-bsc guidewire and isleeve reinserted and non-bsc aortic valve implanted.

• Brand Name: ISLEEVE 14F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18818071
• MDR Text Key: 336680053
• Report Number: 2124215-2024-12578
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0031693637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 05/21/2024; Not provided
• Supplement Dates FDA Received: 05/22/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Sex: Male