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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT PLUS; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT PLUS; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9394
Device Problems Break (1069); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2020
Event Type  malfunction  
Manufacturer Narrative
Age at the time of event: 18 years or older.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the de novo left anterior descending artery.A 2.75x38mm promus element plus drug-eluting stent was advanced for treatment.However, the device could not cross the lesion and the shaft broke.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the de novo left anterior descending artery.A 2.75x38mm promus element plus drug-eluting stent was advanced for treatment.However, the device could not cross the lesion and the shaft broke.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.It was further reported that the target lesion was 80-90% stenosed and was pre-dilated with a balloon.The device was completely removed from the patient's body.
 
Manufacturer Narrative
Age at the time of event: 18 years or older.Device evaluated by mfr: promus element plus, mr, ous 2.75x38mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.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.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube shaft found a break situated at 270mm distal to the distal end of strain relief as well as a multiple hypotube kinks located along the length of the shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the de novo left anterior descending artery.A 2.75x38mm promus element plus drug-eluting stent was advanced for treatment.However, the device could not cross the lesion and the shaft broke.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.It was further reported that the target lesion was 80-90% stenosed and was pre-dilated with a balloon.The device was completely removed from the patient's body.
 
Manufacturer Narrative
Age at the time of event: 18 years or older.
 
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Brand Name
PROMUS ELEMENT PLUS
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10750447
MDR Text Key213664875
Report Number2134265-2020-14961
Device Sequence Number1
Product Code NIQ
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,Followup
Report Date 12/16/2020
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 Date09/29/2021
Device Model Number9394
Device Catalogue Number9394
Device Lot Number0024564337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Initial Date Manufacturer Received 10/08/2020
Initial Date FDA Received10/28/2020
Supplement Dates Manufacturer Received10/27/2020
12/10/2020
Supplement Dates FDA Received11/23/2020
12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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