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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9552
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 01/10/2020
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent fracture occurred.Vascular access was obtained via the right radial artery (lad).The 80% stenosed, 3.5x26mm, concentric, de novo target lesion was located in the non-tortuous and non-calcified left anterior descending artery.The patients ejection fraction was 63%.After a non-bsc guide catheter and a non-bsc guide wire were crossed the lesion, a 28 x 3.50mm promus premier drug-eluting stent was deployed in the lad.However, angiography revealed type 3 stent fracture.Another 3.5x24mm promus premier was used to cover the fractured stent and the procedure completed.No patient complications were reported and the patient's status was stable.
 
Event Description
It was reported that stent fracture occurred.Vascular access was obtained via the right radial artery (lad).The 80% stenosed, 3.5x26mm, concentric, de novo target lesion was located in the non-tortuous and non-calcified left anterior descending artery.The patients ejection fraction was 63%.After a non-bsc guide catheter and a non-bsc guide wire were crossed the lesion, a 28 x 3.50mm promus premier drug-eluting stent was deployed in the lad.However, angiography revealed type 3 stent fracture.Another 3.5x24mm promus premier was used to cover the fractured stent and the procedure completed.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.E1 initial reporter city corrected from (b)(6).
 
Event Description
It was reported that stent fracture occurred.Vascular access was obtained via the right radial artery (lad).The 80% stenosed, 3.5x26mm, concentric, de novo target lesion was located in the non-tortuous and non-calcified left anterior descending artery.The patients ejection fraction was 63%.After a non-bsc guide catheter and a non-bsc guide wire were crossed the lesion, a 28 x 3.50mm promus premier drug-eluting stent was deployed in the lad.However, angiography revealed type 3 stent fracture.Another 3.5x24mm promus premier was used to cover the fractured stent and the procedure completed.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.The device was not returned for analysis, however, procedural media was received for review.The provided images from the angiographic series are not consistent with the reported event of stent fracture.The media review highlighted an initial stent deployed at a lesion site that was not predilated, however no fracture/ gaps/ strut separations were noted post deployment.Post dilation was conducted in stages with distal, mid, and proximal regions of the stent undergoing staged post dilation throughout the length of the stent with a short balloon.Following these post dilations, a second stent is deployed to cover the mid to proximal region of the first stent.Further post dilation of the second stent revealed a constricted region in the proximal region of the stent which was not resolved by multiple postdilation attempts suggesting the presence of calcific nodules.Removal of the postdilation balloon revealed a gap at the same location where the constriction was noted previously, however four stent strut connectors were also visible at the same location linking the stent strut rows as per their intended design.The observation of the stent strut connectors confirms that the stent is conforming to the calcific nodules which led to the misleading conclusion that there was a fracture in the deployed stent.
 
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Brand Name
PROMUS PREMIER
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9648332
MDR Text Key177052259
Report Number2134265-2020-00704
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,foreig
Type of Report Initial,Followup,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/11/2021
Device Model Number9552
Device Catalogue Number9552
Device Lot Number0023378379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2020
Date Manufacturer Received03/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE CATHETER: 3.5 XB 6F; GUIDE CATHETER: 3.5 XB 6F; GUIDE CATHETER: 3.5 XB 6F; GUIDEWIRE: BMW; GUIDEWIRE: BMW; GUIDEWIRE: BMW; GUIDE CATHETER: 3.5 XB 6F; GUIDEWIRE: BMW
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight90
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