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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 9550
Device Problems Fracture (1260); Device Damaged by Another Device (2915)
Patient Problems Chest Pain (1776); Discomfort (2330); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Event Date 09/19/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that the patient experienced discomfort and stent fracture occurred.The severely stenosed target lesion was tortuous and calcified.A 20 x 3.00 promus premier drug-eluting stent was deployed to treat the lesion.Following the initial procedure, the patient felt discomfort.On the second procedure, the implanted stent was found fractured.Since the fractured stent could not be removed, a non-bsc stent was then deployed to cover the fractured stent.No further complications were reported and the patient's status was stable.
 
Event Description
It was reported that the patient experienced discomfort and stent fracture occurred.The severely stenosed target lesion was tortuous and calcified.A 20 x 3.00 promus premier drug-eluting stent was deployed to treat the lesion.Following the initial procedure, the patient felt discomfort.On the second procedure, the implanted stent was found fractured.Since the fractured stent could not be removed, a non-bsc stent was then deployed to cover the fractured stent.No further complications were reported and the patient's status was stable.It was further reported that after the first procedure, the patient experienced chest pain and went under several inspections such as electrocardiography.
 
Manufacturer Narrative
Device is a combination product.
 
Manufacturer Narrative
Device is a combination product.A media clip was received and reviewed.The media shows two stents being positioned and deployed in the mid to proximal left circumflex coronary artery (lcx) followed by two more stents being positioned and deployed mid to proximal left anterior descending artery (lad).After the fourth stent was deployed without issues, a gap is noted at the lad origin.After post-dilation a hazy filling effect, consistent with thrombus, appears in lcx origin due to dissection.An intra-aortic balloon pump is seen being placed.In the follow up procedure the two stented arteries are assessed under flow contrast and a gap is noted at the same site (prox lad) as in the index procedure.A stent is seen placed and deployed at the gap site with several post dilations following.Flow contrast assessment shows that the gap region is not covered by the newly deployed stent and no other issues are noted.The gap region evident at the prox lad of the index and follow up procedures could be attributed to an interaction between the proximally deployed stent in lad and the proximal edge of the stent that was placed at the lcx origin as the final lad stent was being deployed.A strut likely got caught on the stent edge as it was being deployed and deformed the cell structure leaving the gap which persisted after post-dilation.The resultant stent architecture deformity appears as a gap in a way that would be similar to disruption for side-branch access.The gap in the stent cell architecture was successfully filled with an additional stent.A non-flow limiting spiral dissection was seen extending within the stents from mid lm to the prox lad and this likely explains the chest pain the patient experienced.The dissection was healed by the september 12th angiogram.The patient chest pain was most likely due to the extensive dissection from the lm down to lad and lcx but fortunately both vessels were stented.There was no evidence that the device was used in a manner inconsistent with the labelled indications.A device history record was carried out and no issues were noted which could have contributed to the complaint event.There is no evidence that the device failed to meet specification.H3 other text : media review.
 
Event Description
It was reported that the patient experienced discomfort and stent fracture occurred.The severely stenosed target lesion was tortuous and calcified.A 20 x 3.00 promus premier drug-eluting stent was deployed to treat the lesion.Following the initial procedure, the patient felt discomfort.On the second procedure, the implanted stent was found fractured.Since the fractured stent could not be removed, a non-bsc stent was then deployed to cover the fractured stent.No further complications were reported and the patient's status was stable.It was further reported that after the first procedure, the patient experienced chest pain and went under several inspections such as electrocardiography.However, media review revealed dissection and stent damage due to interaction with another device also occurred during the initial procedure.
 
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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 Key9186140
MDR Text Key162511049
Report Number2134265-2019-12143
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 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9550
Device Catalogue Number9550
Device Lot Number0022502805
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2019
Initial Date Manufacturer Received 09/20/2019
Initial Date FDA Received10/14/2019
Supplement Dates Manufacturer Received10/14/2019
12/19/2019
Supplement Dates FDA Received11/08/2019
01/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient Weight68
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