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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 9553
Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Restenosis (4576)
Event Date 05/26/2021
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that angina and restenosis occurred. In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed on the same day. The target lesion 1 was located in the proximal right coronary artery (rca) extending up to mid rca with 85% stenosis and was 64 mm long, with a reference vessel diameter of 3. 5 mm. The lesion was treated with pre-dilatation and placement of a 3. 50 mm x 38 mm and a 3. 50 mm x 32 mm promus premier stent systems. Following this, post-dilatation was performed with residual stenosis as 10%. Seven days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and was hospitalized on the same day for further evaluation and treatment. On the following day, the subject was referred for coronary angiography which revealed 60% stenosis in mid rca which had previously placed study device was treated with percutaneous coronary balloon dilatation (tvr) and percutaneous coronary intervention (pci). Post intervention, residual stenosis was 10%. The rationale of intervention was angina. Two days later, the event was recovered and resolved and, on the same day, the subject was discharged on aspirin and clopidogrel.
 
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Brand NamePROMUS PREMIER
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 Key12471458
MDR Text Key271464605
Report Number2134265-2021-11025
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCH
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 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/19/2020
Device Model Number9553
Device Catalogue Number9553
Device Lot Number0022322444
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 Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2018
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: 09/14/2021 Patient Sequence Number: 1
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