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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 Problems Inflation Problem (1310); Difficult to Remove (1528); Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problems Ventricular Fibrillation (2130); Sudden Cardiac Death (2510); Device Embedded In Tissue or Plaque (3165)
Event Date 09/07/2020
Event Type  Death  
Event Description
It was reported that balloon detachment and patient death occurred. The patient presented with acute infarction. The 80% stenosed target lesion was on the mildly calcified and mildly tortuous anterior descendent and another lesion was located in the right coronary artery. The descendent lesion was predilated with a balloon and the 38 x 2. 75 promus premier drug eluting stent deployed. When the stent balloon was deflated and an attempt was made to remove it from the stent, the balloon detached and remained inside the patient. The physician tried to use a guidewire to remove the balloon without success. Minutes later the patient went into cardiac arrest with ventricular fibrillation and after three rounds of resuscitation maneuvers, the patient was declared dead. The physician considered the balloon left inside the patient, along with the patient being unstable, contributed to the cardiac arrest and death. No autopsy was performed.
 
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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 Key10606346
MDR Text Key209252861
Report Number2134265-2020-12823
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/17/2021
Device Model Number9554
Device Catalogue Number9554
Device Lot Number0024987635
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 Received10/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2019
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: 09/30/2020 Patient Sequence Number: 1
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