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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT-UNI ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE
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BOSTON SCIENTIFIC CORPORATION WALLSTENT-UNI ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number 26650
Device Problem Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 11/06/2020
Event Type  Injury  
Event Description
It was reported that the stent shortened, requiring additional intervention.The target lesion was located in the iliac vein.A 14 x 90mm x 75cm wallstent uni was implanted.However, the device shortened a lot and it was necessary to implant another stent.Another of the same device was implanted to complete the procedure.There were no patient complications reported and the patient was stable.
 
Event Description
It was reported that the stent shortened, requiring additional intervention.The target lesion was located in the iliac vein.A 14 x 90mm x 75cm wallstent uni was implanted.However, the device shortened a lot and it was necessary to implant another stent.Another of the same device was implanted to complete the procedure.There were no patient complications reported and the patient was stable.It was further reported that there was a moderate stenosed lesion.
 
Event Description
It was reported that the stent shortened, requiring additional intervention.The target lesion was located in the iliac vein.A 14 x 90mm x 75cm wallstent uni was implanted.However, the device shortened a lot and it was necessary to implant another stent.Another of the same device was implanted to complete the procedure.There were no patient complications reported and the patient was stable.It was further reported that there was a moderate stenosed lesion.It was further reported that the target lesion was located in a non-tortuous and non-calcified vessel.
 
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Brand Name
WALLSTENT-UNI ENDOPROSTHESIS
Type of Device
PROSTHESIS, TRACHEAL, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10896059
MDR Text Key218007690
Report Number2134265-2020-16249
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/03/2022
Device Model Number26650
Device Catalogue Number26650
Device Lot Number0025669449
Was Device Available for Evaluation? No
Date Manufacturer Received12/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
Patient Weight67
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