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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.

 
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Brand NamePROMUS PREMIER SELECT
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10518400
MDR Text Key206492324
Report Number2134265-2020-11949
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2020
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/23/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/10/2020 Patient Sequence Number: 1
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