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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 9554
Device Problem Obstruction of Flow (2423)
Patient Problems Angina (1710); Restenosis (4576)
Event Date 02/28/2021
Event Type  Injury  
Event Description
Promus premier (b)(4) registry: it was reported that unstable angina and restenosis occurred. In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catherization. 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 distal rca with 95 % stenosis and was 38 mm long, with a reference vessel diameter of 3. 5 mm. The target lesion 1 was treated with pre-dilatation and placement of 3. 50 mm x 38 mm promus premier stent system. Following this post-dilatation was performed with 0% residual stenosis. Additionally, an additional drug eluting stent was implanted during the index procedure. Three days later, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2021, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment. Medication was given to treat the event. On the following day, the subject was referred for coronary angiography which revealed 50% stenosis in proximal rca which had previously placed study device was treated with percutaneous coronary intervention (pci) / target vessel revascularization (tvr). Post intervention, residual stenosis was 0%. It was noted that the rationale of intervention was angina. Two days later, the event was recovered/resolved and the subject was discharged on the same day 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 Key14116195
MDR Text Key289423282
Report Number2134265-2022-04144
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 Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/18/2020
Device Model Number9554
Device Catalogue Number9554
Device Lot Number0022855947
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2018
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: 04/14/2022 Patient Sequence Number: 1
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