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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 Entrapment of Device (1212); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/22/2020
Event Type  malfunction  
Event Description
It was reported that a stent damage and catheter entrapment occurred.The 85% stenosed target lesion area was located in the severely tortuous and severely calcified middle and distal left anterior descending artery.A 4.00x38mm promus element plus drug-eluting stent and a 145 5 in 5 guidezilla guide extension catheter were selected for a percutaneous coronary intervention.After balloon pre-dilatation, the guidezilla and promus were advanced.However, it was noted that the stent got stuck with in the guide extension catheter.The collar of the guidezilla guide extension catheter got detached after retraction and it was found that the stent struts were lifted.The devices were removed completely from the patient's body.The procedure was completed with another of the same device.No complications were reported and the patient status was stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the stent found stent damage with the stent struts along the middle to proximal length damaged, with the proximal stent pulled and stretched over the proximal balloon cone.The undamaged stent od (outer diameter) was measured using a snap gauge and the result was 0.0490", this is 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 examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.The device was loaded onto a 0.0140" guidewire without issue.
 
Event Description
It was reported that a stent damage and catheter entrapment occurred.The 85% stenosed target lesion area was located in the severely tortuous and severely calcified middle and distal left anterior descending artery.A 4.00x38mm promus element plus drug-eluting stent and a 145 5 in 5 guidezilla guide extension catheter were selected for a percutaneous coronary intervention.After balloon pre-dilatation, the guidezilla and promus were advanced.However, it was noted that the stent got stuck with in the guide extension catheter.The collar of the guidezilla guide extension catheter got detached after retraction and it was found that the stent struts were lifted.The devices were removed completely from the patient's body.The procedure was completed with another of the same device.No complications were reported and the patient status was stable.It was further reported that resistance was met in the guidezilla and then the device was removed.
 
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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 Key10373167
MDR Text Key201863308
Report Number2134265-2020-10516
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 09/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/27/2022
Device Model Number9394
Device Catalogue Number9394
Device Lot Number0025140160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2020
Date Manufacturer Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
Patient Weight61
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