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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REBEL; STENT, CORONARY
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BOSTON SCIENTIFIC CORPORATION REBEL; STENT, CORONARY Back to Search Results
Model Number 10271
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/29/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the left main artery (lm).A 12 x 4.50mm rebel stent was advanced for treatment; however, the stent came off the delivery system in the false lumen in lm.The physician was able to implant another stent in the true lumen of the lm which also was able to secure the dislodged stent in the false lumen of the lm.The procedure was completed with patient's status stable.
 
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Brand Name
REBEL
Common Device Name
STENT, CORONARY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8353811
Report Number2134265-2019-01399
Device Sequence Number16693818
Product Code MAF
UDI-Device Identifier08714729843740
UDI-Public08714729843740
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P130030
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/20/2019
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? Yes
Operator of Device Health Professional
Device Expiration Date10/24/2020
Device Model Number10271
Device Catalogue Number10271
Device Lot Number21300114
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/29/2019
Initial Report FDA Received Date02/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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