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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10670
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2023
Event Type  malfunction  
Manufacturer Narrative
B3: date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.Device evaluated by manufacturer: promus elite ous mr 8 x 3.00mm stent delivery system was returned for analysis.The following attributes were examined: stent profile: a visual and microscopic examination of the crimped stent found no damage.The stent showed no signs of movement and was set between the proximal and distal marker bands.Balloon profile: the balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Tip profile: a visual and microscopic examination of the bumper tip found no issues.Hypotube profile: the device was received in two sections as a result of a break in the hypotube.The break was located at 86.5cm distal to the distal end of the strain relief.Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.
 
Event Description
Reportable based on device analysis completed on 18 april 2023.A 8x3.00mm promus elite balloon expandable stent was selected for a percutaneous coronary intervention procedure.The returned promus elite balloon expandable stent revealed a hypotube detachment.No patient complications were reported and the patient was stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: promus elite ous mr 8 x 3.00mm stent delivery system was returned for analysis.The following attributes were examined: stent profile: a visual and microscopic examination of the crimped stent found no damage.The stent showed no signs of movement and was set between the proximal and distal marker bands.Balloon profile: the balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Tip profile: a visual and microscopic examination of the bumper tip found no issues.Hypotube profile: the device was received in two sections as a result of a break in the hypotube.The break was located at 86.5cm distal to the distal end of the strain relief.Shaft polymer extrusion profile: a visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.
 
Event Description
Reportable based on device analysis completed on 18april2023.A 8x3.00mm promus elite balloon expandable stent was selected for a percutaneous coronary intervention procedure.The returned promus elite balloon expandable stent revealed a hypotube detachment.No patient complications were reported and the patient was stable.It was further reported that the lesion was 70% stenosed, calcified and not tortuous located in the pla1.A 8x3.00mm promus elite broke within the guiding catheter during advancement.The 8x3.00mm promus elite and the guiding catheter were removed together.The procedure was cancelled, patient was given a new appointment.The patient was awake, stable and responsive post procedure.
 
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Brand Name
PROMUS ELITE
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16781049
MDR Text Key313733853
Report Number2124215-2023-18265
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10670
Device Catalogue Number10670
Device Lot Number0030251177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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