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

Model Number	10445
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypovolemic Shock (1917); Vascular Dissection (3160)
Date of Event	09/23/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that vessel dissection and patient death occurred.During a complex transcatheter aortic valve replacement (tavr) procedure, vascular access was obtained via a transfemoral approach with a minimum femoral artery diameter of 4.7mm.The mildly calcified native aortic annulus measured 20.6mm in diameter.A 14f isleeve introducer sheath was placed and safari2 guidewire was advanced into position.Balloon aortic valvuloplasty (bav) was performed with one (1) inflation of a 20mm non-boston scientific (bsc) balloon catheter.A size small acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds).The acurate neo2 tf ds was advanced into position, commissural alignment was achieved, and the acurate neo2 valve was released.The aortic gradient post implant was 5mmhg.After implant of the acurate neo2 valve when the 14f isleeve introducer sheath was removed a dissection of the iliac artery was identified.Three (3) non-bsc coated stents were implanted.The patient experienced severe blood loss.Five (5) days post implant procedure the patient died.The official cause of death was hemorrhagic shock caused by vascular complications.
Additional Manufacturer Narrative
H6 evaluation method codes updated.H6 evaluation result codes updated.H6 evaluation conclusion codes updated.Media analysis: a 3mensio report and five (5) filmed sequences of isolated steps within the procedure (no comprehensive recording was available) were provided to assist in the investigation and were reviewed by a bsc medical director.No imaging pertinent to the reported vessel dissection were provided.The femoral access measured 4.7mm for the left femoral artery and 4.8mm for the right femoral artery.There was no report of femoral vascular modification technique before the insertion of the 14f isleeve introducer sheath.
Event or Problem Description
It was reported that vessel dissection and patient death occurred.During a complex transcatheter aortic valve replacement (tavr) procedure, vascular access was obtained via a transfemoral approach with a minimum femoral artery diameter of 4.7mm.The mildly calcified native aortic annulus measured 20.6mm in diameter.A 14f isleeve introducer sheath was placed and safari2 guidewire was advanced into position.Balloon aortic valvuloplasty (bav) was performed with one (1) inflation of a 20mm non-boston scientific (bsc) balloon catheter.A size small acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds).The acurate neo2 tf ds was advanced into position, commissural alignment was achieved, and the acurate neo2 valve was released.The aortic gradient post implant was 5mmhg.After implant of the acurate neo2 valve when the 14f isleeve introducer sheath was removed a dissection of the iliac artery was identified.Three (3) non-bsc coated stents were implanted.The patient experienced severe blood loss.One (1) day post implant procedure the patient died.The official cause of death was vascular complications.It was further reported the cause of death was hemorrhagic shock caused by vascular complications.

• Brand Name: ISLEEVE 14F
• Common Device Name: 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: 20346812
• Report Number: 2124215-2024-60091
• Device Sequence Number: 8023992
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2025
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0032629428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 36 KG