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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2023
Event Type  Death  
Manufacturer Narrative
E1: initial reporter phone: (b)(6).E1: initial reporter fax: (b)(6).
 
Event Description
Promus premier china registry.It was reported that the patient died.In (b)(6) 2018, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal left circumflex artery (lcx) with 90% stenosis and was 28 mm long, with a reference vessel diameter of 2.5 mm.The target lesion 1 was treated with placement of a 2.75 mm x 32 mm promus premier stent system.Following post dilatation, the residual stenosis was noted to be 10%.In (b)(6) 2019, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject died.At the time of the event the subject was on aspirin and clopidogrel.The primary cause of death was unknown.There was no other action taken to treat the event and it is unknown if an autopsy was performed.
 
Manufacturer Narrative
E1: initial reporter phone: (b)(6).
 
Event Description
Promus premier china registry.It was reported that the patient died.In (b)(6) 2018, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal left circumflex artery (lcx) with 90% stenosis and was 28 mm long, with a reference vessel diameter of 2.5 mm.The target lesion 1 was treated with placement of a 2.75 mm x 32 mm promus premier stent system.Following post dilatation, the residual stenosis was noted to be 10%.In (b)(6) 2019, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject died.At the time of the event the subject was on aspirin and clopidogrel.The primary cause of death was unknown.There was no other action taken to treat the event and it is unknown if an autopsy was performed.It was further reported that the primary cause of death was cardiac related.
 
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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 CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19196278
MDR Text Key341191785
Report Number2124215-2024-25455
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 Other,Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/18/2024
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? No
Device Operator Health Professional
Device Expiration Date06/07/2020
Device Model Number9553
Device Catalogue Number9553
Device Lot Number0022275440
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/24/2024
Initial Date FDA Received04/26/2024
Supplement Dates Manufacturer Received06/06/2024
Supplement Dates FDA Received06/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age84 YR
Patient SexMale
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