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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
Device Problem Material Deformation (2976)
Patient Problems Angina (1710); Heart Failure/Congestive Heart Failure (4446); Restenosis (4576)
Event Date 08/20/2023
Event Type  Injury  
Manufacturer Narrative
Date of event: 08/20/2023 used as approximate event date as actual event date is unknown.Copy of literature article attached to this report.
 
Event Description
It was reported that a stent deformation occurred.A promus premier stent was used for treatment during a procedure that occurred 8 years ago.5 years later, the patient begam experiencing angina and heart failure.It was revealed through angiography that the implanted stent had severe deformation at the proximal right coronary artery (rca).Angiography also showed restenosis of the rca.A non-boston scientific balloon was advanced and used to successfully re-expand the promus stent.
 
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Brand Name
PROMUS PREMIER
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19187825
MDR Text Key341115518
Report Number2124215-2024-24939
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/25/2024
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/25/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient SexFemale
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