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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 Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2021
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The patient presented with may thurner syndrome.The 71.3mm x 16.71mm, 50% compressed target lesion was located in the non-calcified and mildly tortuous left iliac vein.Following pre-dilatation of a 8x 100mm balloon catheter, a 16 x 40mm x 75cm wallstent-uni endoprosthesis was advanced for treatment.The physician then noticed that the stent was not opening to the expected diameter.The device was fully reconstrained and removed from the patient.The physician deployed the stent again outside the patient, it was noted that the distal part of the stent strut was unbraided and lifted.Another 16 x 40mm x 75cm wallstent-uni endoprosthesis was used, however, the stent did not expand.It was also noticed outside the patient that the stent strut was also lifted.The procedure was completed with another of same device.There were no patient complications reported.The patient status was stable.
 
Event Description
It was reported that stent damage occurred.The patient presented with may thurner syndrome.The 71.3mm x 16.71mm, 50% compressed target lesion was located in the non-calcified and mildly tortuous left iliac vein.Following pre-dilatation of a 8x 100mm balloon catheter, a 16 x 40mm x 75cm wallstent-uni endoprosthesis was advanced for treatment.The physician then noticed that the stent was not opening to the expected diameter.The device was fully reconstrained and removed from the patient.The physician deployed the stent again outside the patient, it was noted that the distal part of the stent strut was unbraided and lifted.Another 16 x 40mm x 75cm wallstent-uni endoprosthesis was used, however, the stent did not expand.It was also noticed outside the patient that the stent strut was also lifted.The procedure was completed with another of same device.There were no patient complications reported.The patient status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: a wallstent uni 16 x 40mm x 75cm was received for analysis.The device was received with the stent in the correct position on the device.The investigator successfully deployed the stent without resistance or issue experienced.A microscopic examination found no damage or issues with the deployed stent.A visual and microscopic examination identified no damage or issues with the delivery system, shaft or tip of the device that could potentially have contributed to the complaint incident.No issues were identified during the product analysis.
 
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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 Key12198139
MDR Text Key262505683
Report Number2134265-2021-09212
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,distri
Type of Report Initial,Followup
Report Date 09/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/19/2022
Device Model Number26650
Device Catalogue Number26650
Device Lot Number0025068223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Initial Date Manufacturer Received 07/01/2021
Initial Date FDA Received07/20/2021
Supplement Dates Manufacturer Received08/20/2021
Supplement Dates FDA Received09/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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