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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ISLEEVE 15F INTRODUCER, CATHETER Back to Search Results
Model Number 10445
Device Problem Material Deformation (2976)
Patient Problems Death (1802); Aortic Dissection (2491)
Event Date 09/01/2020
Event Type  Death  
Event Description
It was reported that there was a dissection and death occurred. The patient had severe abdominal aortic calcification. Access was gained through a right transfemoral approach. A 25mm lotus edge valve (lot 25699511) was advanced through and past the tip of the isleeve introducer approximately 10mm. An aortic dissection near the distal end of the isleeve introducer was observed. Calcification was present in the area of the dissection; the dissection was believed to be as a result of the isleeve sheath near the calcification. The lotus edge valve delivery system and isleeve introducer were removed without difficulty. The lotus edge valve (lot 25699511) had kinks approximately 1 inch from the tip and 3-4 inches from the tip. The isleeve introducer was appropriately expanded and also had a kink. An angiogram was taken and confirmed the dissection. The abdominal aorta was repaired with a graft. After the repair, a new isleeve introducer was advanced through the graft successfully. A new 25mm lotus edge valve was implanted successfully. Later that day, the patient died. The cause of death is believed to be a result of the abdominal aorta dissection caused by the introducer sheath.
 
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Brand NameISLEEVE 15F
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10546685
MDR Text Key207327303
Report Number2134265-2020-12332
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/22/2021
Device Model Number10445
Device Catalogue Number10445
Device Lot Number0024477043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
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