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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 10662
Device Problem Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 06/03/2020
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.
 
Event Description
It was reported that stent fracture occurred: a percutaneous coronary intervention was being performed on a 75% stenosed ostial lesion in the proximal left circumflex coronary artery.The lesion was predilated with several balloons, including a non-boston scientific 1.5x15mm balloon at 16atm for 7 seconds, then an apex quantum 2.5x12mm at 22atm for 7 seconds, and then an apex quantum 3.0x20mm at 20 atm for 7 seconds.After this the 12x3.50mm promus premier select drug-eluting stent was implanted at 16atm for 5 seconds.After implantation the stent seemed to be fractured.The stent was post dilated with the apex quantum 2.5x15mm at 12 atm for 9 seconds, then the apex 3.0x15mm at 18 atm for 10 seconds and finally with an apex quantum 3.5x8 mm at 22 atm for 5 seconds.A second 3.5x8mm promus premier select drug-eluting stent was implanted in the fractured stent area.There were no adverse patient effects and the patient was stable.
 
Event Description
It was reported that stent fracture occurred: a percutaneous coronary intervention was being performed on a 75% stenosed ostial lesion in the proximal left circumflex coronary artery.The lesion was predilated with several balloons, including a non-boston scientific 1.5x15mm balloon at 16atm for 7 seconds, then an apex quantum 2.5x12mm at 22atm for 7 seconds, and then an apex quantum 3.0x20mm at 20 atm for 7 seconds.After this the 12x3.50mm promus premier select drug-eluting stent was implanted at 16atm for 5 seconds.After implantation the stent seemed to be fractured.The stent was post dilated with the apex quantum 2.5x15mm at 12 atm for 9 seconds, then the apex 3.0x15mm at 18 atm for 10 seconds and finally with an apex quantum 3.5x8 mm at 22 atm for 5 seconds.A second 3.5x8mm promus premier select drug-eluting stent was implanted in the fractured stent area.There were no adverse patient effects and the patient was stable.
 
Manufacturer Narrative
A2 - age at time of event: 18 years or older a cd was received and reviewed which contained one series of angiographic images, dated (b)(6) 2020.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 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 (allowed by the stent's 2 connector and 4-connector design) to the vessel anatomy by considering the presence of fibro-calcific lesions and provide the required scaffolding without any straightening of the vessel.
 
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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 Key10518400
MDR Text Key206492324
Report Number2134265-2020-11949
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
Report Date 10/09/2020
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 Expiration Date07/22/2020
Device Model Number10662
Device Catalogue Number10662
Device Lot Number0022445621
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/13/2020
Initial Date FDA Received09/10/2020
Supplement Dates Manufacturer Received09/23/2020
Supplement Dates FDA Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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