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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 9386
Device Problems Break (1069); Premature Activation (1484); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/05/2020
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.(b)(6).
 
Event Description
It was reported that stent premature deployment occurred.Vascular access was obtained via the radial artery.The 70% stenosed, 15mmx2.6mm target lesion containing a bend of >45 and <90 degree was located in the moderately tortuous and moderately calcified diagonal.After a non-bsc guide catheter and non-bsc guidewire were crossed the lesion, pre-dilatation was performed with a 2x15 emerge balloon catheter resulting to 60% stenosis.A 2.50x20mm promus element plus drug-eluting stent was advanced for treatment.However, during procedure, the stent was deployed partially before the target lesion.The stent was implanted in the same artery to avoid dislodgement.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
 
Manufacturer Narrative
E1 initial reporter address 1: (b)(6).The promus element plus, mr, ous 2.50 x 20 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent was detached and not returned for analysis as it was implanted in the radial artery where the stent detachment had occurred.The balloon body was reviewed; no issues were noted on the balloon cones.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Crimp markings were visible on the balloon.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found a hypotube break at 23 cm distal to the distal end of the strain relief, multiple kinks were also noted along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent premature deployment occurred.Vascular access was obtained via the radial artery.The 70% stenosed, 15mmx2.6mm target lesion containing a bend of >45 and <90 degree was located in the moderately tortuous and moderately calcified diagonal.After a non-bsc guide catheter and non-bsc guidewire were crossed the lesion, pre-dilatation was performed with a 2x15 emerge balloon catheter resulting to 60% stenosis.A 2.50x20mm promus element plus drug-eluting stent was advanced for treatment.However, during procedure, the stent was deployed partially before the target lesion.The stent was implanted in the same artery to avoid dislodgement.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.It was further reported that the stent was not prematurely deployed but instead was dislodged inside the patient.Resistance was encountered while attempting to cross the lesion with the device.Additional support was provided with a non-boston scientific (bsc) guide wire.Several pushes were attempted but the shaft was found to be kinked.When an attempt was make to remove the device, the stent dislodged and found in the radial artery.The shaft was then confirmed to be broken outside the patient.
 
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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 Key10195724
MDR Text Key196443104
Report Number2134265-2020-07833
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
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/07/2020
Device Model Number9386
Device Catalogue Number9386
Device Lot Number0022255370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Date Manufacturer Received10/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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