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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT LONG STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT LONG STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9315
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Sudden Cardiac Death (2510)
Event Date 06/27/2019
Event Type  Death  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that sudden cardiac arrest and death occurred. Vascular access was obtained via the femoral artery. A percutaneous transluminal coronary angioplasty (ptca) was performed on an 80% stenosed target lesion in the non calcified, non tortuous left anterior descending artery (lad) and obtuse marginal (om). Following predilatation, a 3. 00 x 38mm promus element long was deployed in the distal lad, a 3. 50 x 16mm promus element was deployed in the proximal lad, and a 3. 00 x 24mm promus element was deployed in the om. After three hours of ptca, the patient had sudden cardiac arrest and died in the coronary care unit (ccu) due to a reason unknown.
 
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Brand NamePROMUS ELEMENT LONG
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8754293
MDR Text Key149826147
Report Number2134265-2019-07669
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
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 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/25/2020
Device Model Number9315
Device Catalogue Number9315
Device Lot Number0022752629
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 Received07/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2018
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: 07/02/2019 Patient Sequence Number: 1
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