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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 Problems Break (1069); Activation Failure (3270)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/15/2024
Event Type  Injury  
Manufacturer Narrative
E1: initial reporter phone: (b)(6).
 
Event Description
It was reported that a shaft break occurred, resulting in un-retrieved device fragment.A 12 x 4.00mm promus premier select stent balloon expandable was selected for treatment.During the procedure, a fracture was noted resulting in an unretrieved device fragment.The patient was admitted to hospital beyond the standard of care.No further information is available.
 
Manufacturer Narrative
B5: describe event or problem: updated.H6: device codes: updated.E1: initial reporter phone: (b)(6).
 
Event Description
It was reported that a shaft break occurred, resulting in unretrieved device fragment.A 12 x 4.00mm promus premier select stent balloon expandable was selected for treatment.During the procedure, a fracture was noted resulting in an unretrieved device fragment.The patient was admitted to hospital beyond the standard of care.No further information is available.It was further reported that target lesion was very tortuous.Stent was deployed partially, and procedure was completed successfully.Patient was discharged from the hospital.
 
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Brand Name
PROMUS PREMIER SELECT
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 Key19073075
MDR Text Key339736591
Report Number2124215-2024-20885
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/08/2024
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
Device Model Number10662
Device Catalogue Number10662
Device Lot Number0031125744
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2024
Initial Date FDA Received04/09/2024
Supplement Dates Manufacturer Received04/15/2024
Supplement Dates FDA Received05/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2023
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) Other; Hospitalization;
Patient Age7 MO
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