MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE 15F; INTRODUCER, CATHETER

Model Number 10445

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)

Event Date 10/07/2020

Event Type  Death  

Event Description

It was reported that hypotension, perforation, and death occurred.The patient was selected for a 27mm lotus edge valve implant and noted to have mild to moderate leaflet calcification.The patient was noted to have a gastrointestinal bleed prior to the procedure.A 15f isleeve introducer sheath was inserted into the right femoral artery and a 27mm lotus edge valve system was advanced.The lotus edge valve delivery catheter was hydrated with saline prior to insertion.The wet dry gauze technique was not used during advancement.Continuous flushing was done during insertion.During advancement, there was active back traction on the safari2 guidewire used.The 27mm lotus edge valve system was difficult to introduce and force was required to advance the lotus edge valve system through the 15f isleeve introducer sheath.A kink was noted in the 15 isleeve introducer sheath.The lotus edge valve was not advanced past the tip of the 15f isleeve introducer sheath before the kink was noted.The kink was near the proximal to mid portion of the 15f isleeve introducer sheath.The 27mm lotus edge valve system was removed through the 15f isleeve introducer sheath with a lot of back tension on the device.The 15f isleeve introducer sheath and the 27mm lotus edge valve system were removed from the patient separately.After removal, the patients blood pressure dropped significantly.Contrast was injected which showed that a perforation with extravasation was present.A covered stent was placed in the right iliac artery and chest compressions were started.The patients blood pressure and heart rhythm never returned to stable values and the patient died.

Manufacturer Narrative

Device eval by mfr: the isleeve sheath and tip were microscopically examined.There are numerous sheath kinks along the device and all of the seams have started to expand.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that hypotension, perforation, and death occurred.The patient was selected for a 27mm lotus edge valve implant and noted to have mild to moderate leaflet calcification.The patient was noted to have a gastrointestinal bleed prior to the procedure.A 15f isleeve introducer sheath was inserted into the right femoral artery and a 27mm lotus edge valve system was advanced.The lotus edge valve delivery catheter was hydrated with saline prior to insertion.The wet dry gauze technique was not used during advancement.Continuous flushing was done during insertion.During advancement, there was active back traction on the safari2 guidewire used.The 27mm lotus edge valve system was difficult to introduce and force was required to advance the lotus edge valve system through the 15f isleeve introducer sheath.A kink was noted in the 15 isleeve introducer sheath.The lotus edge valve was not advanced past the tip of the 15f isleeve introducer sheath before the kink was noted.The kink was near the proximal to mid portion of the 15f isleeve introducer sheath.The 27mm lotus edge valve system was removed removed through the 15f isleeve introducer sheath with a lot of back tension on the device.The 15f isleeve introducer sheath and the 27mm lotus edge valve system were removed from the patient separately.After removal, the patients blood pressure dropped significantly.Contrast was injected which showed that a perforation with extravasation was present.A covered stent was placed in the right iliac artery and chest compressions were started.The patients blood pressure and heart rhythm never returned to stable values and the patient died.

• Brand Name: ISLEEVE 15F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10769910
• MDR Text Key: 214087863
• Report Number: 2134265-2020-14434
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2022
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0025800691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 78 YR