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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10663
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 08/25/2020
Event Type  Injury  
Event Description
It was reported that stent fracture occurred.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified left anterior descending artery.A 16 x 3.00mm promus premier select dug-eluting stent was implanted for treatment.However, fracture was noted on the proximal segment.Another stent was used to cover the fractured stent, completing the procedure.No patient complications were reported and the patient status was stable.
 
Event Description
It was reported that stent fracture occurred.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified left anterior descending artery.A 16 x 3.00mm promus premier select dug-eluting stent was implanted for treatment.However, fracture was noted on the proximal segment.Another stent was used to cover the fractured stent, completing the procedure.No patient complications were reported and the patient status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was not returned to the complaint investigation site (cis) therefore device analysis could not be performed however procedural media was received.A single angiographic image was received.The single series review shows a view of the left coronary arteries without flow contrast.The distal end of a guidecatheter is noted along a guidewire through one of the left coronary arteries.A deployed stent can be seen with the markerbands of a smaller postdilation balloon visible inside (distal markerband) and outside (proximal markerband) of the expanded stent.An apparent gap in the proximal region of the stent is noted suggesting strut displacement at that section of the lesion however a strut connector is also noted on the site of the gap.Additionally, a constricted region is also noted coinciding with what appears to be the first stent strut row; however, no gaps are noted.The series reviewed shows the distal end of a guidecatheter along with a guidewire trough the left main arteries.A deployed stent is noted with the markerbands from a postdilation balloon.A gap pointing to strut displacement is noted on the proximal to mid-section of this stent suggesting strut displacement at that region, additionally a stent strut connector is seen at the gap site.A further constricted region is noted coinciding with the first proximal stent strut row but without displaying any gap or strut displacement.This is indicative of calcific nodules at the site of the gap as per event description the lesion site was 80 % stenosed.A review of the media provided could not identify the alleged stent fracture however a gap which could indicate strut displacement was noted in the proximal to mid stent region.The apparent strut displacement noted could have appeared to the physician as stent fracture however this was not the case as the displaced struts visible in the media review along with the constricted region most likely represent a conformation of the stent to the vessel anatomy by considering the presence of fibro-calcific lesions and provide the required scaffolding without any straightening of the vessel.Additionally the coplanar view from which we are seeing the stent could mislead to assume that there is a stent fracture when in fact what we are seeing is two strut connectors on the same plane on view (one behind the other) and this is why only one of them is visible.
 
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Brand Name
PROMUS PREMIER SELECT
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10474087
MDR Text Key205089285
Report Number2134265-2020-12060
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 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/08/2022
Device Model Number10663
Device Catalogue Number10663
Device Lot Number0025065238
Was Device Available for Evaluation? No
Date Manufacturer Received09/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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