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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10677
Device Problems Material Rupture (1546); Failure to Advance (2524); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Event Description
It was reported that balloon rupture and partial stent deployment occurred. The 60% stenosed target lesion was located in the mildly tortuous and moderately calcified anterior descending artery. Angioplasty was performed with a 2. 5 x 15mm wolverine cutting balloon. A 38 x 3. 00 promus elite stent was advanced for treatment. However, the device failed to cross the proximal part of the lesion. A guidezilla extension catheter was used to allow the passage of the stent. During deployment of the stent, the balloon burst on the initial inflation at 12 atmospheres and the stent was released within the artery without adequate apposition. The stent was retrieved and the entire rail system removed without complication. The procedure was completed with a 3. 0 x 38mm non-boston scientific stent. No patient complications were reported, and the patient status was stable.
 
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Brand NamePROMUS ELITE
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 Key13588862
MDR Text Key286062164
Report Number2134265-2022-01951
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10677
Device Catalogue Number10677
Device Lot Number0027278253
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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